Systems and methods for decompression, elliptical traction, and linear traction of the occiput, cervical spine, and thoracic spine

ABSTRACT

A traction device comprises a frame, a first bladder portion, a second bladder portion, and a third inflatable bladder portion. The first bladder expands in an outward direction a distance greater than in a transverse direction. The second bladder expands in a first angular direction. The second bladder is positioned generally inferior to and to the side of the first bladder. The third bladder expands in a second angular direction. Upon expanding in the outward direction, the first bladder bears against the back of the user&#39;s neck. Upon expanding in the transverse direction, the first bladder applies an angular traction to the cervical spine. Upon expanding in the first angular direction, the second bladder bears angularly against the back of the user&#39;s upper thoracic region. Upon expanding in the third angular direction, the third bladder bears angularly against the user&#39;s occiput.

CROSS-REFERENCE TO RELATED APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication, are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND Field

Disclosed herein are spinal decompression and traction systems andmethods related to the field of spinal treatment. More particularly,certain embodiments disclosed herein relate to occipital, cervical andthoracic spinal decompression and traction systems having a plurality ofinflatable bladders and methods of use that maintain, enhance andrestore a normal lordotic curve and counter hyper-kyphosis of the upperand mid thoracic spine.

Description of the Related Art

Cervical pain is one of the most common health-related complaints. Whenthere are no neurological deficits, symptomatic relief of pain is oftensought with either non-steroidal analgesics, or various physical therapymodalities, including cervical traction. Most traction has consisted ofaxial linear distraction employing various head/chin straps and weightsof 20 to 25 pounds. Such traction tends to straighten the cervicalspine, removing its normal curve and often results in TMJ pain.

The undamaged cervical spine normally defines a forward or lordoticcurve of about 43° (measured from C2-C7) whereby weight is distributedon hard individual bony articular surfaces in the posterior and softintervertebral discs to the anterior. Without such a forward curve inthe cervical spine, weight of the head transfers forward onto the softnon-bony intervertebral discs and vertebral bodies causing discs todehydrate, wear, degenerate and protrude into the anterior subarachnoidspace. As vertebral bodies bear uneven stress, spurs and osteophytesform. Additionally, individuals with lost or reversed (buckled) cervicalspinal curves eventually exhibit a significant loss of natural jointmovement, further limiting the normal canaliculus seepage and imbibitionof adjacent fluids via vertebral end plates and annuli. Without suchnutrient rich fluids the discs continue to dehydrate, further weakeningthe discs, resulting in a further loss of mobility, degeneration andpossible nerve damage. Active nutrient transport is particularlyimportant because the intervertebral discs' indigenous vascular supplyoften disappears at approximately 20 years of age.

Further, as the cervical spine is forced into flexion and the lordoticcurve is reversed, the dura, cord and nerve-roots are drawn out; theroot-sleeves come into contact with the pedicles, and the nerve rootswith the inner surfaces of the sleeves. During extension (lordotic curverecovery) the dura, cord and nerve-roots in the cervical canal areslack; the root-sleeves have lost contact with the pedicles and thenerve-roots with the inner surfaces of the sleeves.

Axial/Linear/Longitudinal traction has long been employed to decompresscervical joints of the spine. Typically the head is pulled, pried,lifted or otherwise separated from the thorax along the Y axis (+Y axistranslation or elevation translation). Ostensibly, to pry the jointsapart at the posterior, forward flexion (+X axis rotation) is oftenemployed in conjunction with or as an unavoidable component of lineartraction. Linear traction or elevation translation applied to a curvedcolumn decreases or removes the curve. Likewise, adding the component offlexion or +rotation about the X axis, would apply a buckling force tothe cervical spine and have the effect of reversing the curve (−Z axistranslation). These forces, powerful enough to separate the spinaljoints, are unfortunately antithetical to the natural geometry andbiomechanics of the human cervical spine. The anchor points commonlyused in Axial/Linear/Longitudinal traction are the head as it is pulledaway from the thorax and/or the trapezius muscles as the thorax ispushed away from the restrained head. U.S. Pat. No. 4,805,603 toCumberland describes a method where the head and thorax are separated bytwo platforms with an expanding air chamber between the two platforms.These methods, due to their linear function reduce, remove or reversethe proper cervical curve. U.S. Pat. No. 6,506,174 to Saunders alsodescribes a linear traction system.

Some alternatives to axial/linear/longitudinal traction for disc, jointand nerve decompression seek to maintain a normal lordotic curve. Forexample, U.S. Pat. Nos. 5,382,226; 5,569,176; 5,713,841; 5,906,586;7,060,085; 8,029,453; and D508,5665 to Graham, each of which is herebyincorporated by reference herein in its entirety, disclose someembodiments of systems for decompression. In two IRB approved studiesutilizing multiple MRI's, an embodiment of the disclosed systems showeda consistent ability to draw bulging disc material back toward the discproper and away from the subarachnoid space and spinal cord whilesimultaneously enhancing or restoring the cervical lordotic curve duringand after one 20 minute treatment. Patients reported immediatesymptomatic relief of cervical pain. However, there exists a need forimproved decompression systems that also address hyper-kyphosis of theupper thoracic spine, mid thoracic spine and compression of theoccipital-cervical junction.

SUMMARY

Described herein are some embodiments of decompression and tractionsystems that maintain, enhance and restore a normal lordotic curve,counter hyper-kyphosis of the upper and mid thoracic spine anddecompress the occipital-cervical junction. Methods of assembling andusing the decompression and traction systems described herein are alsoincluded. These decompression and traction systems and related methodsare described in greater detail below.

One aspect of the present invention is the recognition thattraditionally available traction systems do not provide devices, systemsand methods that simultaneously address cervical lordotic curveloss/reversal (hypolordosis/kyphosis), and the often accompanyingposterior (−Z) translation (hyper-kyphosis) of the upper thoracic spine.Embodiments and methods described herein preferably provide pneumaticradial decompression and traction equipment for treatment of thecervical and thoracic spine including a free-standing frame, first andsecond expandable bladders, the first expandable bladder providingpositive pressure to support a cervical spinal portion in a normallordotic curve configuration, and the second expandable bladderproviding positive pressure to support a thoracic spinal portion in anormal curve configuration to counter hyper-kyphosis of the upperthoracic spine.

According to certain embodiments of the invention, devices, systems andmethods are described that simultaneously address cervical lordoticcurve loss/reversal (hypolordosis/kyphosis), and the often accompanyingposterior (−Z) translation (hyper-kyphosis) of the upper thoracic spine.

In relation to the head and neck, −Z translation of the upper thoracicspine is an integral part of anterior or “Forward Head Carriage.” As thehead shifts forward and/or the upper thoracic spine moves posterior, theweight of the head and neck, approximately 15 pounds, creates a forwardbuckling force (−Y and +Z combination) on the thoracic spine. Thiscontinuous forward and downward force begets more forward head carriageand more compressive action to the cervical and thoracic intervertebraldiscs and bodies. Many are familiar with the term “Dowagers Hump” wherehyper kyphosis of the thoracic spine is so pronounced as to be obviouswith the naked eye. While approximately 30% of these postural defects(especially in women) are said to be caused by anterior thoracicvertebral body fractures due to osteoporosis, most hyper-kyphoticpostures are developed over time by continuous anterior and downwardforce on the cervical and thoracic intervertebral discs and vertebralbodies.

As people spend long hours crouched in front of computer screens, wearheavy back packs, are involved whiplash type auto and sports injuries,forward head posture with associated cervical curve loss, and hyperthoracic kyphosis has become more prevalent. Neck and back pain, muscletension and spasm, headaches, neuropathies and degenerative vertebraljoint disease result from continuous cervical-thoracic disc and jointcompression. While there have been elastic bands and braces applied tothe spine to pull or hold it upright in an attempt to ameliorateworsening posture, results are mixed.

In some embodiments, the devices, systems and methods described hereinapply pneumatic forces directly to the offending spinal apexes inopposing directions. With the simultaneous application of two separateair cells or pneumatic air chambers the cervical spine is locked andpowerfully decompressed into its proper lordotic or curved configuration(<{circumflex over ( )}>) with −Y+Z+Y force vectors while the hyperkyphotic area of the upper thoracic spine is simultaneously decompressedwith a combination +Z/−Y force mid-vector. The cervical spine's lordoticcurve is powerfully decompressed and enhanced while the thoracichyper-kyphosis is simultaneously reduced. In some embodiments, a twopump system can be employed to alternate or unevenly inflate thepneumatic air chambers. In some embodiments, a complex multi vectoredpneumatic air chamber can be used in place of two individual cells. Insome embodiments, the devices, systems and methods described herein usethe entire cervical spine including the occiput (base of skull) as afirst anchor point and the upper thoracic spine as a second point. Thepneumatic air chambers can directly contact the cervical spine/occiputand the upper 25% of the thoracic spine.

According to one embodiment, a traction device comprises a frame, afirst bladder portion, a second bladder portion, a strap, and a pump.The first bladder expands in an outward direction a distance greaterthan in a transverse direction. The second bladder expands in an angulardirection. The second bladder is positioned generally below and to theside of the first bladder. The frame is secured to the user's head. Uponexpanding in the outward direction, the first bladder bears against theback of the user's neck and forces the cervical spine to curveforwardly. Upon expanding in the transverse direction, the first bladderapplies an angular traction to the cervical spine. Upon expanding in theangular direction, the second bladder bears angularly against the backof the user's upper thoracic region and forces the thoracic spine todecompress and reduces hyper-kyphosis of the upper thoracic spine.

In certain embodiments, a traction device for imparting a forward curveto the cervical spine and reducing hyper-kyphosis of the upper thoracicspine is provided. The device comprises a frame adapted to be supportedon a rigid support surface. The frame is configured to be disposed abouta user's head and neck and defines contact surfaces for abutting therigid support surface. The frame has a neck support extending betweenfirst and second side portions of the frame. A first inflatableelongated bladder is coupled to the neck support and configured to bepositioned below a neck of a user during use. The first inflatableelongated bladder is expandable in a first direction outwardly from theneck support toward the neck of a user and expandable in a seconddirection substantially normal to the first direction upon inflation. Asecond inflatable elongated bladder is coupled to the neck support andconfigured to be positioned below the upper thoracic region of a userduring use. The second inflatable elongated bladder is expandable in athird direction angularly from the neck support toward the upperthoracic spine of a user upon inflation. A securing strap is coupled tothe frame and configured to secure the frame to the user's head suchthat the first inflatable elongated bladder is disposed adjacent theback of the user's neck and transverses the cervical spine such that thefirst direction of expansion is toward and substantially normal to thecervical spine. The second inflatable elongated bladder is disposedadjacent the back of the user's upper thoracic region and transversesthe upper thoracic spine such that the third direction of expansion istoward and substantially normal to the upper thoracic spine. A pumpsystem is provided for selectively inflating and deflating the first andsecond inflatable elongated bladders. Upon the first inflatable bladderexpanding in the first direction, the first inflatable bladder bearsoutwardly against the back of the user's neck and forces the cervicalspine to curve forwardly. Upon expanding in the second direction, thefirst inflatable bladder applies an angular traction to the cervicalspine. Upon the second inflatable bladder expanding in the thirddirection, the second inflatable bladder bears angularly against theback of the user's upper thoracic region and forces the thoracic spineto decompress and reduces hyper-kyphosis of the upper thoracic spine.

In some embodiments, the traction device comprises a valve positioned incommunication with the pump system and the first and second inflatableelongated bladders. The valve comprises varying lumen diameters thatdirect flow between the pump system and the first and second inflatableelongated bladders. The first inflatable elongated bladder is pivotablycoupled to the neck support. A spacer is configured to be coupledbetween a portion of the frame and the second inflatable elongatedbladder to adjust the angulation of the second inflatable elongatedbladder during inflation.

In other embodiments, a traction device is provided for imparting aforward curve to the cervical spine and reducing hyper-kyphosis of theupper thoracic spine. The device comprises a frame having a transverseneck support projecting upwardly from first and second side portionsdefining a base of the frame. A first inflatable bladder portion iscoupled to the neck support. The first inflatable bladder portion isconfigured to expand in an outward direction from the neck support adistance greater than the expansion of the first inflatable bladderportion in a transverse direction normal thereto. A second inflatablebladder portion is coupled to the neck support. The second inflatablebladder portion is configured to expand in an angular direction from theneck support. The second inflatable bladder portion is positionedgenerally below and to the side relative to the first inflatable bladderportion. A strap is coupled to the frame and configured to secure theframe to the user's head such that the first inflatable bladder portionis disposed adjacent the back of the user's neck and transverses thecervical spine such that the outward direction of expansion is towardand substantially normal to the cervical spine. The second inflatablebladder portion is disposed adjacent the back of the user's upperthoracic region and transverses the upper thoracic spine such that theangular direction of expansion is toward and substantially normal to theupper thoracic spine. A pump system is provided for inflating the firstand second inflatable bladder portions. Upon the first inflatablebladder portion expanding in the outward direction, the first inflatablebladder portion bears outwardly against the back of the user's neck andforces the cervical spine to curve forwardly. Upon expanding in thetransverse direction, the first inflatable bladder portion applies anangular traction to the cervical spine. Upon the second inflatablebladder portion expanding in the angular direction, the secondinflatable bladder portion bears angularly against the back of theuser's upper thoracic region and forces the thoracic spine to decompressand reduces hyper-kyphosis of the upper thoracic spine.

In some embodiments, a method is provided for imparting a forward curveto the cervical spine and reducing hyper-kyphosis of the upper thoracicspine. The method comprises securing a traction device to a user's head.The traction device comprises a support frame having a transverse necksupport projecting upwardly from a base of the support frame and firstand second inflatable bladder portions coupled to the neck support. Thetraction device is secured to the user's head includes positioning thetraction device such that the first inflatable bladder portiontransverses the cervical spine, and such that the second inflatablebladder portion transverses the upper thoracic spine. The firstinflatable bladder portion is expanded in a direction outward from theneck support and toward and substantially normal to the cervical spineto force the cervical spine to curve forwardly. The first inflatablebladder portion is expanded in a transverse direction to apply anangular traction to the cervical spine. The second inflatable bladderportion is expanded in a direction toward and substantially normal tothe upper thoracic spine to force the upper thoracic spine to decompressand reduce hyper-kyphosis of the upper thoracic spine.

In certain embodiments, methods may comprise alternately inflating anddeflating the first and second bladder portions. Inflation and deflationof the first and second bladder portions can be repeated. The firstinflatable bladder portion can have a semi-ellipsoidal configurationupon inflation. The second inflatable bladder portion can have asemi-ellipsoidal configuration upon inflation. During inflation ordeflation, flow can be directed between the pump system and the bladderportion through a valve that comprises different lumen diameters toprovide particular flow to or from the first and second inflatablebladder portions. Methods can include pivoting the first inflatablebladder relative to the neck support and/or positioning a spacer betweena portion of the frame and the second inflatable bladder portion toadjust the angulation of the second inflatable bladder portion duringinflation.

In some embodiments, a traction device is provided for imparting aforward curve to the cervical spine and reducing hyper-kyphosis of theupper thoracic spine. The device comprises a frame adapted to besupported on a rigid support surface. The frame is configured to bedisposed about a user's head and neck and defines contact surfaces forabutting the rigid support surface. The frame has a neck supportextending between first and second side portions of the frame. A firstinflatable elongated bladder is coupled to the neck support andconfigured to be positioned below a neck of a user during use. The firstinflatable elongated bladder is expandable in a first directionoutwardly from the neck support toward the neck of a user and expandablein a second direction substantially normal to the first direction uponinflation. A second inflatable elongated bladder is coupled to the necksupport and configured to be positioned below the upper thoracic regionof a user during use. The second inflatable elongated bladder isexpandable in a third direction angularly from the neck support towardthe upper thoracic spine of a user upon inflation. A spacer isconfigured to be coupled between a portion of the frame and the secondinflatable elongated bladder to adjust the angulation of the secondinflatable elongated bladder during inflation. A pump system is providedfor selectively inflating and deflating the first and second inflatableelongated bladders. Upon the first inflatable bladder expanding in thefirst direction, the first inflatable bladder bears outwardly againstthe back of the user's neck, and upon expanding in the second direction,the first inflatable bladder applies an angular traction to the cervicalspine. Upon the second inflatable bladder expanding in the thirddirection, the second inflatable bladder bears angularly against theback of the user's upper thoracic region.

In certain embodiments, a traction device for imparting a forward curveto the cervical spine and reducing hyper-kyphosis of the upper thoracicspine comprises a frame having a transverse neck support projectingupwardly from first and second side portions defining a base of theframe. A first inflatable bladder portion is coupled to the necksupport, the first inflatable bladder portion is configured to expand inan outward direction from the neck support a distance greater than theexpansion of the first inflatable bladder portion in a transversedirection normal thereto. A second inflatable bladder portion is coupledto the neck support. The second inflatable bladder portion is configuredto expand in an angular direction from the neck support. The secondinflatable bladder portion is positioned generally below and to the siderelative to the first inflatable bladder portion. A spacer is configuredto be coupled between a portion of the frame and the second inflatablebladder portion to adjust the angulation of the second inflatablebladder portion during inflation. A pump system is provided forinflating the first and second inflatable bladder portions. Upon thefirst inflatable bladder portion expanding in the outward direction, thefirst inflatable bladder portion bears outwardly against the back of theuser's neck. Upon expanding in the transverse direction, the firstinflatable bladder portion applies an angular traction to the cervicalspine. Upon the second inflatable bladder portion expanding in theangular direction, the second inflatable bladder portion bears angularlyagainst the back of the user's upper thoracic region.

According to some implementations, additional features include awedge-shaped spacer, a rotatable spacer, and/or a spacer in a horizontalposition that is configured to adjust the angulation of the secondinflatable bladder portion during inflation to provide lateral flexiontraction. Other spacer systems are contemplated and can also be used.For example, any component or device that can be selectively adjustedand can contact at least a portion of the second inflatable bladderportion can be used to impart lateral flexion traction. Additionally, insome cases a component or device need not be adjustable, for example, aspacer or other component could be provided on a traction device tocause the second inflatable bladder portion to consistently provide forlateral flexion traction on one side, while other systems can providefor lateral flexion traction on the other side. Additionally, whileadjustments made with the spacer may be rotational, other movements oradjustments can be made with other mechanisms and arrangements, such asby sliding, for example.

According to another implementation, a method of imparting a forwardcurve to the cervical spine and reducing hyper-kyphosis of the upperthoracic spine is provided. A traction device is secured to a user'shead. The traction device comprises a support frame having a transverseneck support projecting upwardly from a base of the support frame andfirst and second inflatable bladder portions coupled to the neck supportand a spacer coupled between a portion of the frame and the secondinflatable bladder portion to adjust the angulation of the secondinflatable bladder portion during inflation to provide lateral flexiontraction. Securing the traction device to the user's head includespositioning the traction device such that the first inflatable bladderportion transverses the cervical spine, and such that the secondinflatable bladder portion transverses the upper thoracic spine. Thefirst inflatable bladder portion is expanded in a direction outward fromthe neck support and toward and substantially normal to the cervicalspine to force the cervical spine to curve forwardly. The firstinflatable bladder portion is expanded in a transverse direction toapply an angular traction to the cervical spine. The second inflatablebladder portion is expanded in a direction toward the upper thoracicspine to provide lateral flexion traction. In some embodiments, thespacer is rotated to adjust the angulation of the second inflatablebladder portion.

According to certain embodiments of the invention, devices, systems andmethods are described that address compression of the occipital-cervicaljunction. In some embodiments, the devices, systems, and methodsdescribed herein apply pneumatic forces directly to the occiput.

In certain embodiments of the invention, devices, systems and methodsare described that simultaneously address cervical lordotic curveloss/reversal (hypolordosis/kyphosis), the often accompanying posterior(−Z) translation (hyper-kyphosis) of the upper thoracic spine, andcompression of the occipital-cervical junction. With the application ofan air cell or pneumatic air chamber, the occipital-cervical junction isdecompressed by the application of +Z/+Y force vectors.

In some embodiments, the devices, systems, and methods described hereinapply pneumatic forces directly to the offending spinal apexes inopposing directions and to the occiput. With the simultaneousapplication of three separate air cells or pneumatic air chambers thecervical spine is locked and powerfully decompressed into its properlordotic or curved configuration (<{circumflex over ( )}>) with −Y+Z+Yforce vectors while the hyper kyphotic area of the upper thoracic spineis simultaneously decompressed with a combination +Z/−Y force mid-vectorand +Z/+Y force vectors are applied to the occiput to decompress theoccipital-cervical junction. The cervical spine's lordotic curve ispowerfully decompressed and enhanced while the thoracic hyper-kyphosisis simultaneously reduced and the occipital-cervical junction isdecompressed. In some embodiments, a two pump system can be employed toalternate or unevenly inflate the pneumatic air chambers. In someembodiments, a three pump system can be employed to alternate orunevenly inflate the pneumatic air chambers. In some embodiments, acomplex multi vectored pneumatic air chamber can be used in place ofthree individual cells. In some embodiments, the devices, systems andmethods described herein use the entire cervical spine as a first anchorpoint, the upper thoracic spine as a second point, and the occiput as athird point. The pneumatic air chambers can directly contact thecervical spine/occiput and the upper 25%-40% of the thoracic spine.

In certain embodiments, a traction device is provided. The devicecomprises a frame having a base and a neck support coupled to the baseto support the neck of a user during use, a first inflatable bladderportion coupled to the neck support, a second inflatable bladder portioncoupled to the neck support, and a third inflatable bladder portioncoupled to the neck support. The first inflatable bladder portion isconfigured to expand in an outward direction from the neck supporttoward the neck of a user and to expand in a transverse directionsubstantially normal to the outward direction upon inflation. The secondinflatable bladder portion is configured to expand in a first angulardirection from the neck support and is positioned generally inferior tothe first inflatable bladder portion. The third inflatable bladderportion is configured to expand in a second angular direction from theneck support and is positioned generally superior to the firstinflatable bladder portion. Upon the first inflatable bladder portionexpanding in the outward direction, the first inflatable bladder portionbears outwardly against the back of the neck of the user as the firstinflatable bladder is inflated and forces the cervical spine to curveforwardly, and upon expanding in the transverse direction, the firstinflatable bladder portion applies an angular traction to the cervicalspine as the first inflatable bladder is inflated. Upon the secondinflatable bladder portion expanding in the first angular direction, thesecond inflatable bladder portion bears angularly against the back ofthe upper thoracic region of the user as the second inflatable bladderis inflated and forces the thoracic spine to decompress and reduceshyper-kyphosis of the upper thoracic spine. Upon the third inflatablebladder portion expanding in the second angular direction, the thirdinflatable bladder portion bears angularly against the occiput of theuser as the third inflatable bladder is inflated and forces theoccipital-cervical junction to decompress.

In certain embodiments, a spacer is configured to be coupled between aportion of the frame and the second inflatable bladder portion to adjustthe angulation of the second inflatable bladder portion duringinflation. In certain embodiments, a spacer is configured to be coupledbetween a portion of the frame and the third inflatable bladder portionto adjust the angulation of the third inflatable bladder portion duringinflation. In certain embodiments, a pump system is provided forinflating the first, second, and third inflatable bladder portions. Incertain embodiments, a valve is positioned in communication with thepump system and the first inflatable bladder portion, the secondinflatable bladder portion, and the third inflatable bladder portion,wherein the valve comprises varying lumen diameters that direct flowbetween the pump system and the first inflatable bladder portion, thesecond inflatable bladder portion, and the third inflatable bladderportion. In certain embodiments, upon inflation, the third inflatablebladder portion can impart 15° to 20° of forward head flexion to theocciput of the user.

According to some implementations, additional features include awedge-shaped spacer, a rotatable spacer, and/or a spacer in a horizontalposition that is configured to adjust the angulation of the secondinflatable bladder portion during inflation to provide lateral flexiontraction. Other spacer systems are contemplated and can also be used.For example, any component or device that can be selectively adjustedand can contact at least a portion of the second inflatable bladderportion can be used to impart lateral flexion traction. Additionally, insome cases a component or device need not be adjustable, for example, aspacer or other component could be provided on a traction device tocause the second inflatable bladder portion to consistently provide forlateral flexion traction on one side, while other systems can providefor lateral flexion traction on the other side. Additionally, whileadjustments made with the spacer may be rotational, other movements oradjustments can be made with other mechanisms and arrangements, such asby sliding, for example.

According to some implementations, additional features include awedge-shaped spacer, a rotatable spacer, and/or a spacer in a horizontalposition that is configured to adjust the angulation of the thirdinflatable bladder portion during inflation to provide lateral flexiontraction. Other spacer systems are contemplated and can also be used.For example, any component or device that can be selectively adjustedand can contact at least a portion of the third inflatable bladderportion can be used to impart lateral flexion traction. Additionally, insome cases a component or device need not be adjustable, for example, aspacer or other component could be provided on a traction device tocause the second inflatable bladder portion to consistently provide forlateral flexion traction on one side, while other systems can providefor lateral flexion traction on the other side. Additionally, whileadjustments made with the spacer may be rotational, other movements oradjustments can be made with other mechanisms and arrangements, such asby sliding, for example.

In some embodiments, the devices, systems, and methods described hereinapply pneumatic forces directly to the cervical spine and the occiput.With the simultaneous application of two separate air cells or pneumaticair chambers the cervical spine is locked and powerfully decompressedinto its proper lordotic or curved configuration (<{circumflex over( )}>) with −Y+Z+Y force vectors the occipital-cervical junction issimultaneously decompressed with +Z/+Y force vectors. The cervicalspine's lordotic curve is powerfully decompressed and enhanced while theoccipital-cervical junction is decompressed. In some embodiments, a twopump system can be employed to alternate or unevenly inflate thepneumatic air chambers. In some embodiments, a complex multi vectoredpneumatic air chamber can be used in place of two individual cells. Insome embodiments, the devices, systems and methods described herein usethe entire cervical spine as a first anchor point, and the occiput as asecond point.

In certain embodiments, a traction device is provided. The tractiondevice comprises a frame having a base and a neck support coupled to thebase to support the neck of a user during use, a first inflatablebladder portion coupled to the neck support, and a second inflatablebladder portion coupled to the neck support. The first inflatablebladder portion is configured to expand in an outward direction from theneck support toward the neck of the user and in a transverse directionsubstantially normal to the outward direction upon inflation. The secondinflatable bladder portion is configured to be positioned superior tothe first inflatable bladder portion and is expandable in an angulardirection from the neck support toward an occiput of the user uponinflation. Upon the first inflatable bladder portion expanding in theoutward direction, the first inflatable bladder portion bears outwardlyagainst the back of the neck of the user as the first inflatable bladderis inflated and forces the cervical spine to curve forwardly, and uponexpanding in the transverse direction, the first inflatable bladderportion applies an angular traction to the cervical spine as the firstinflatable bladder is inflated. Upon the second inflatable bladderportion expanding in the angular direction, the second inflatablebladder portion bears angularly against the occiput of the user as thesecond inflatable bladder is inflated and forces the occipital-cervicaljunction to decompress.

In certain embodiments, a spacer is configured to be coupled between aportion of the frame and the second inflatable bladder portion to adjustthe angulation of the second inflatable bladder portion duringinflation. In certain embodiments, a pump system is provided forselectively inflating and deflating one or more of the first and secondinflatable bladder portions. In certain embodiments, a valve ispositioned in communication with the pump system and the first andsecond inflatable bladder portions, wherein the valve comprises varyinglumen diameters that direct flow between the pump system and the firstand second inflatable bladder portions.

According to some implementations, additional features include awedge-shaped spacer, a rotatable spacer, and/or a spacer in a horizontalposition that is configured to adjust the angulation of the secondinflatable bladder portion during inflation to provide lateral flexiontraction. Other spacer systems are contemplated and can also be used.For example, any component or device that can be selectively adjustedand can contact at least a portion of the second inflatable bladderportion can be used to impart lateral flexion traction. Additionally, insome cases a component or device need not be adjustable, for example, aspacer or other component could be provided on a traction device tocause the second inflatable bladder portion to consistently provide forlateral flexion traction on one side, while other systems can providefor lateral flexion traction on the other side. Additionally, whileadjustments made with the spacer may be rotational, other movements oradjustments can be made with other mechanisms and arrangements, such asby sliding, for example.

In certain embodiments, a method of imparting a forward curve to thecervical spine and reducing hyper-kyphosis of the upper thoracic spineis provided. The method comprises a step of securing a traction deviceto a head of a user. The traction device comprises a support framehaving a transverse neck support projecting upwardly from a base of thesupport frame and first and second inflatable bladder portions coupledto the neck support. Securing the traction device to the head comprisespositioning the traction device such that the first inflatable bladderportion transverses the cervical spine, and such that the secondinflatable bladder portion transverses an occiput of the user. Themethod further comprises a step of expanding the first inflatablebladder portion in a direction outward from the neck support and towardand substantially normal to the cervical spine to force the cervicalspine to curve forwardly. The method also comprises a step of expandingthe first inflatable bladder portion in a transverse direction to applyan angular traction to the cervical spine. The method further comprisesa step of expanding the second inflatable bladder portion in a directiontoward the occiput to apply an angular traction to theoccipital-cervical junction.

In some embodiments, the method further comprising a step of alternatelyinflating and deflating the first and second bladder portions. In someembodiments, the method further comprises a step of repeating inflationand deflation of the first and second bladder portions. In someembodiments, the second inflatable bladder portion has asemi-ellipsoidal configuration upon inflation. In some embodiments, thetraction device comprises a third inflatable bladder portion coupled tothe neck support. In some embodiments, securing the traction device tothe head comprises positioning the traction device such that the thirdinflatable bladder portion transverses the upper thoracic spine. In someembodiments, the method further comprises a step of inflating the thirdbladder portion in a direction toward the upper thoracic spine to forcethe thoracic spine to decompress and reduce hyper-kyphosis of the upperthoracic spine. In some embodiments, the traction device comprises avalve positioned in communication with a pump system and the firstinflatable bladder portion, the second inflatable bladder portion, andthe third inflatable bladder portion. In some embodiments, the methodfurther comprises a step of directing flow from the pump system throughthe valve to the first inflatable bladder portion, the second inflatablebladder portion, and the third inflatable bladder portion.

In some embodiments, the devices, systems, and methods described hereinapply pneumatic forces directly to the thoracic spine and to theocciput. With the simultaneous application of two separate air cells orpneumatic air chambers, the hyper kyphotic area of the upper thoracicspine is simultaneously decompressed with a combination +Z/−Y forcemid-vector and the occipital-cervical junction is decompressed with+Z/+Y force vectors. The thoracic hyper-kyphosis is simultaneouslyreduced and the occipital-cervical junction is decompressed. In someembodiments, the simultaneous application of two separate air cells orpneumatic air chambers, to the thoracic spine and the occiput can impartlinear traction. In some embodiments, a two pump system can be employedto alternate or unevenly inflate the pneumatic air chambers. In someembodiments, a complex multi vectored pneumatic air chamber can be usedin place of two individual cells. In some embodiments, the devices,systems and methods described herein use the upper thoracic spine as afirst anchoring point and the occiput as a second point. The pneumaticair chambers can directly contact the cervical spine/occiput and theupper 25%-40% of the thoracic spine.

In certain embodiments, a traction device is provided. The tractiondevice comprises a frame having a base and a neck support coupled to thebase to support the neck of a user during use, a first inflatablebladder portion coupled to the neck support, and a second inflatablebladder portion coupled to the neck support. The first inflatablebladder portion is configured to expand a first angular direction fromthe neck support. The second inflatable bladder portion is configured tobe positioned superior to the first inflatable bladder portion and isexpandable in a second angular direction from the neck support toward anocciput of the user upon inflation. Upon the first inflatable bladderportion expanding in the first angular direction, the first inflatablebladder portion bears angularly against the back of the upper thoracicregion of the user as the second inflatable bladder is inflated andforces the thoracic spine to decompress and reduces hyper-kyphosis ofthe upper thoracic spine. Upon the second inflatable bladder portionexpanding in the angular direction, the second inflatable bladderportion bears angularly against the occiput of the user as the secondinflatable bladder is inflated and forces the occipital-cervicaljunction to decompress.

In certain embodiments, a spacer is configured to be coupled between aportion of the frame and the second inflatable bladder portion to adjustthe angulation of the second inflatable bladder portion duringinflation. In certain embodiments, a pump system is provided forselectively inflating and deflating one or more of the first and secondinflatable bladder portions. In certain embodiments, a valve ispositioned in communication with the pump system and the first andsecond inflatable bladder portions, wherein the valve comprises varyinglumen diameters that direct flow between the pump system and the firstand second inflatable bladder portions.

According to some implementations, additional features include awedge-shaped spacer, a rotatable spacer, and/or a spacer in a horizontalposition that is configured to adjust the angulation of the firstinflatable bladder portion during inflation to provide lateral flexiontraction. Other spacer systems are contemplated and can also be used.For example, any component or device that can be selectively adjustedand can contact at least a portion of the first inflatable bladderportion can be used to impart lateral flexion traction. Additionally, insome cases a component or device need not be adjustable, for example, aspacer or other component could be provided on a traction device tocause the second inflatable bladder portion to consistently provide forlateral flexion traction on one side, while other systems can providefor lateral flexion traction on the other side. Additionally, whileadjustments made with the spacer may be rotational, other movements oradjustments can be made with other mechanisms and arrangements, such asby sliding, for example.

According to some implementations, additional features include awedge-shaped spacer, a rotatable spacer, and/or a spacer in a horizontalposition that is configured to adjust the angulation of the secondinflatable bladder portion during inflation to provide lateral flexiontraction. Other spacer systems are contemplated and can also be used.For example, any component or device that can be selectively adjustedand can contact at least a portion of the second inflatable bladderportion can be used to impart lateral flexion traction. Additionally, insome cases a component or device need not be adjustable, for example, aspacer or other component could be provided on a traction device tocause the second inflatable bladder portion to consistently provide forlateral flexion traction on one side, while other systems can providefor lateral flexion traction on the other side. Additionally, whileadjustments made with the spacer may be rotational, other movements oradjustments can be made with other mechanisms and arrangements, such asby sliding, for example.

In certain embodiments, a traction device is provided. The tractiondevice comprises a frame having a base and a neck support coupled to thebase to support the neck of a user during use and an inflatable bladderportion coupled to the neck support. The inflatable bladder portion isconfigured to expand in an angular direction from the neck support. Uponthe inflatable bladder portion expanding in the angular direction, theinflatable bladder portion bears angularly against the back of the upperthoracic region and the mid thoracic region of the user as theinflatable bladder is inflated and forces the thoracic spine todecompress and reduces hyper-kyphosis of the upper thoracic spine andthe mid thoracic spine.

In certain embodiments, the inflatable bladder portion is a firstinflatable bladder portion and the angular direction is a first angulardirection. In certain embodiments, the traction device further comprisesa second inflatable bladder portion coupled to the neck support, and thesecond inflatable bladder portion bladder portion is expandable in asecond angular direction from the neck support toward a occiput of theuser upon inflation. In certain embodiments, upon the second inflatablebladder portion expanding in the second angular direction, the secondinflatable bladder portion bears angularly against the occiput of theuser as the second inflatable bladder is inflated and forces theoccipital-cervical junction to decompress the occipital-cervicaljunction. In certain embodiments, the traction device further comprisesa third inflatable bladder portion coupled to the neck support, and thethird inflatable bladder portion is configured to expand in an outwarddirection from the neck support toward the neck of the user and in atransverse direction substantially normal to the outward direction uponinflation. In certain embodiments, upon the third inflatable bladderportion expanding in the outward direction, the third inflatable bladderportion bears outwardly against the back of the neck of the user as thethird inflatable bladder is inflated and forces the cervical spine tocurve forwardly, and upon expanding in the transverse direction, thethird inflatable bladder portion applies an angular traction to thecervical spine as the third inflatable bladder is inflated.

In certain embodiments, the inflatable bladder portion is a firstinflatable bladder portion, and the traction device further comprises asecond inflatable bladder portion coupled to the neck support. Incertain embodiments, the second inflatable bladder portion is configuredto expand in an outward direction from the neck support toward the neckof the user and in a transverse direction substantially normal to theoutward direction upon inflation. In certain embodiments, upon thesecond inflatable bladder portion expanding in the outward direction,the second inflatable bladder portion bears outwardly against the backof the neck of the user as the second inflatable bladder is inflated andforces the cervical spine to curve forwardly, and upon expanding in thetransverse direction, the second inflatable bladder portion applies anangular traction to the cervical spine as the second inflatable bladderis inflated.

In certain embodiments, a spacer is configured to be coupled between aportion of the frame and the inflatable bladder portion to adjust theangulation of the inflatable bladder portion during inflation. Incertain embodiments, a pump system is provided for selectively inflatingand deflating the inflatable bladder portion. In certain embodiments, avalve is positioned in communication with the pump system and theinflatable bladder portion, wherein the valve comprises varying lumendiameters that direct flow between the pump system and the inflatablebladder portion.

According to some implementations, additional features include awedge-shaped spacer, a rotatable spacer, and/or a spacer in a horizontalposition that is configured to adjust the angulation of the inflatablebladder portion during inflation to provide lateral flexion traction.Other spacer systems are contemplated and can also be used. For example,any component or device that can be selectively adjusted and can contactat least a portion of the inflatable bladder portion can be used toimpart lateral flexion traction. Additionally, in some cases a componentor device need not be adjustable, for example, a spacer or othercomponent could be provided on a traction device to cause the inflatablebladder portion to consistently provide for lateral flexion traction onone side, while other systems can provide for lateral flexion tractionon the other side. Additionally, while adjustments made with the spacermay be rotational, other movements or adjustments can be made with othermechanisms and arrangements, such as by sliding, for example.

These and other objects and advantages of the present disclosure willbecome readily apparent from the following detailed description taken inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of a decompression andtraction system.

FIG. 2 is a perspective view of a portion of the system shown in FIG. 1.

FIG. 3 is a top view of a portion of the system shown in FIG. 1.

FIG. 4 is a side view of a portion of the system shown in FIG. 1.

FIG. 5 is a cross-sectional side view of a portion of the system shownin FIG. 1.

FIG. 6 is a perspective view of a valve component shown in thecross-sectional side view of FIG. 5.

FIG. 7 is a perspective view of a portion of the system shown in FIG. 1,showing a second inflatable bladder in an unassembled configuration.

FIG. 8 is a schematic view of another embodiment of a decompression andtraction system, showing mobile pneumatic air chambers comprising afirst inflatable bladder being pivotably adjustable and showing a spacercomponent configured to be selectively coupled to the frame to adjust aposition of a second inflatable bladder.

FIG. 9 is a perspective view of the spacer component shown in FIG. 8.

FIGS. 10A-F are illustrative views of a patient's spine in multipleconfigurations, including some embodiments of decompression and tractionsystems in use in deflated and inflated configurations.

FIG. 11 is a schematic top view of a patient positioned on anotherembodiment of a decompression and traction system, showing pneumatic airchambers comprising first and second inflatable bladders and anadjustable spacer component configured to be selectively coupled to theframe to adjust a position of the second inflatable bladder, in theshown configuration the spacer component adjusts the position of thesecond inflatable bladder to provide an even distribution of forcegenerally along a force vector in the −Y and +Z plane.

FIG. 12 is a schematic top view of a patient and the embodiment of FIG.11, showing a configuration wherein the spacer component is moved toadjust the position of the second inflatable bladder to provide anuneven distribution of force on one side of the patient in that a forcevector is directed, for example, in a −Y, +Z, and −X direction.

FIG. 13 is a bottom view of the embodiment of FIG. 11, in the shownconfiguration the spacer component adjusts the position of the secondinflatable bladder to provide an even distribution of force generallyalong a force vector in the −Y and +Z plane.

FIG. 14 is a bottom view of the embodiment of FIG. 11, showing aconfiguration wherein the spacer component is moved to adjust theposition of the second inflatable bladder to provide an unevendistribution of force to a patient in that a force vector is directed,for example, in a −Y, +Z, and −X direction.

FIG. 15 is a perspective view of one embodiment of a decompression andtraction system.

FIG. 16 is a perspective view of a portion of the system shown in FIG.15.

FIG. 17 is a top view of a portion of the system shown in FIG. 15.

FIG. 18 is a side view of a portion of the system shown in FIG. 15.

FIG. 19 is a cross-sectional side view of a portion of the system shownin FIG. 15.

FIG. 20 is a perspective view of a valve component shown in thecross-sectional side view of FIG. 19.

FIG. 21 is a perspective view of a portion of the system shown in FIG.15, showing a third inflatable bladder in an unassembled configuration.

FIG. 22 is a schematic view of another embodiment of a decompression andtraction system, showing mobile pneumatic air chambers comprising afirst inflatable bladder being pivotably adjustable, showing a spacercomponent configured to be selectively coupled to the frame to adjust aposition of a second inflatable bladder, and showing a spacer componentconfigured to be selectively coupled to the frame to adjust a positionof a third inflatable bladder.

FIGS. 23A-B are illustrative views of a patient's spine includingembodiments of decompression and traction systems in use in inflatedconfigurations.

FIG. 24 is a schematic top view of a patient positioned on anotherembodiment of a decompression and traction system, showing pneumatic airchambers comprising first, second, and third inflatable bladders, afirst adjustable spacer component configured to be selectively coupledto the frame to adjust a position of the second inflatable bladder,wherein in the shown configuration the spacer component adjusts theposition of the second inflatable bladder to provide an evendistribution of force generally along a force vector in the −Y and +Zplane, and a second adjustable spacer component configured to beselectively coupled to the frame to adjust a position of the thirdinflatable bladder, wherein in the shown configuration the spacercomponent adjusts the position of the third inflatable bladder toprovide an even distribution of force generally along a force vector inthe +Y and +Z plane

FIG. 25 is a schematic top view of a patient and the embodiment of FIG.24, showing a configuration wherein the first spacer component is movedto adjust the position of the second inflatable bladder to provide anuneven distribution of force on one side of the patient in that a forcevector is directed, for example, in a −Y, +Z, and −X direction, andwherein the second spacer component is moved to adjust the position ofthe third inflatable bladder to provide an uneven distribution of forceon one side of the patient in that a force vector is directed, forexample, in a +Y, +Z, and −X direction.

FIG. 26 is a bottom view of the embodiment of FIG. 24, in the shownconfiguration the first spacer component adjusts the position of thesecond inflatable bladder to provide an even distribution of forcegenerally along a force vector in the −Y and +Z plane and the secondspacer component adjusts the position of the second inflatable bladderto provide an even distribution of force generally along a force vectorin the +Y and +Z plane.

FIG. 27 is a bottom view of the embodiment of FIG. 24, showing aconfiguration wherein the first spacer component is moved to adjust theposition of the second inflatable bladder to provide an unevendistribution of force to a patient in that a force vector is directed,for example, in a −Y, +Z, and −X direction and the second spacercomponent is moved to adjust the position of the third inflatablebladder to provide an uneven distribution of force to a patient in thata force vector is directed, for example, in a +Y, +Z, and −X direction.

FIG. 28 is a perspective view of one embodiment of a decompression andtraction system.

FIG. 29 is a perspective view of one embodiment of a decompression andtraction system.

FIG. 30 is an illustrative view of a patient's spine including anembodiment of a decompression and traction systems in use in an inflatedconfiguration.

DETAILED DESCRIPTION

According to some preferred embodiments, the devices, systems andmethods described herein relate to a decompression and traction systemfor imparting the desired lordotic shape into the cervical region of thespine and counteracting hyper-kyphosis of the area of the upper thoracicspine. Some systems can be used to work the spine and surrounding tissueto promote fluid and cellular exchange in and around the intervertebraldiscs.

In some embodiments, the device comprises a frame, a first substantiallyellipsoidal inflatable bladder transversely in a neck support cradlecarried by the frame, a second inflatable bladder supported on the necksupport cradle carried by the frame and configured to provide a forcevector against the upper thoracic spine when inflated, one or morerestraining straps for securing the device to the user's head such thatthe first and second bladders are disposed against the back of the neckunder a stress point in the cervical spine and against thehyper-kyphotic upper thoracic spine, respectively. Controlled inflationof the bladders by the user by a hand-held pump causes a controlledlifting and a stretching of the cervical and thoracic spine. As thefirst bladder is inflated, the configuration of the first bladder causesthe first bladder to expand vertically and, to a lesser extent,transversely. The vertical expansion lifts the spine, creating a spinalapex while the transverse expansion of the bladder applies an angulartraction to the neck on both sides of the apex. As the second bladder isinflated, preferably simultaneously, the configuration of the secondbladder causes the second bladder to expand vertically and transversely.The vertical and transverse expansion lifts the spine and applies anangular traction to the thoracic region.

By controlling the inflation of the bladders, the user can control thelifting and stretching of the spine and incrementally increase themagnitude of spinal arc and decompression of the cervical and thoracicregions to his or her own tolerance. As the bladders are repetitivelyinflated to the tolerance of the user and deflated, the cervical spineis alternatively and actively forced from a lesser arc to a greater orhyper-lordotic arc and the hyper-kyphotic arc of the upper thoracicspine is simultaneously reduced and decompressed, thereby promotingnutrient transport to the intervertebral discs while simultaneouslyincreasing the cervical lordotic arc and decreasing the thoracichyper-kyphosis. These decompression and traction systems and relatedmethods are described in greater detail below.

Referring now to the drawings, as shown in FIGS. 1-5, according to oneembodiment, a traction device 110 comprises a frame 112, openings orslots 114 configured to receive one or more straps to restrain theforehead and/or chin of a user, a first inflatable air bladder 116, asecond inflatable air bladder 118, and an air pump assembly 120.

The frame 112 is preferably molded of a durable plastic material in atubular configuration so as to define a pair of side members 122 and 124curved and meeting at an apex 126, and a transverse neck support 128.The frame side members 122 and 124 preferably form a stable base. Theneck support 128 preferably comprises vertically extending portions 130and 132 which project upwardly from the side members 122 and 124respectively and project inwardly to define inwardly directed raisedlateral portions 134 and 136. A neck cradle 138 extends transverselybetween portions 134 and 136, spanning frame side members 122 and 124.In some embodiments, the frame can be provided with side members thatare not connected at an apex 126, such as in some embodiments where sidemembers are shorter.

The first and second air bladders 116 and 118 are preferably configuredfor inflation and simultaneous application of force to the cervical andthoracic spine, when the patient is in a treatment position, todecompressed the spine into its proper lordotic or curved configuration(<{circumflex over ( )}>) with −Y+Z+Y force vectors being applied to thecervical spine while the hyper-kyphotic area of the upper thoracic spineis simultaneously decompressed with a combination +Z/−Y forcemid-vector. The cervical spine's lordotic curve is powerfullydecompressed and enhanced while the thoracic hyper-kyphosis issimultaneously reduced. In some embodiments, the devices, systems andmethods described herein use the entire cervical spine including theocciput (base of skull) as the first anchor point and the upper thoracicspine as the second point. The pneumatic air chambers can directlycontact the cervical spine/occiput and the upper 25%-40% of the thoracicspine. The first and second inflatable bladders 116, 118, are describedin more detail below.

To provide selective inflation and deflation of the first and secondinflatable bladders 116, 118, a flexible air line 140 of the air pumpassembly 120 communicates the interior of the first and secondinflatable bladders 116, 118 with a hand-operated air pump 142. In otherembodiments an automated pump can be used. A pressure relief valve 144is preferably disposed between the air line 140 and pump 142. Air line140 preferably extends from the relief valve 144 through an opening inthe neck support 128 and communicates with the first and secondinflatable bladders 116, 118. In some embodiments, the air can becommunicated through openings formed in the underside or ends of thebladders. In some embodiments, a valve 146, such as a multi-directionalmetering valve, shown in FIGS. 5 and 6 for example, can be coupled withthe air line 140 and can direct air to the first and second inflatablebladders 116, 118. In some embodiments the valve 146 comprises differentlumen diameters to vary the air flow directed to the opposing tractionpneumatic air chambers of the first and second inflatable bladders 116,118. Different valve components can be used to adjust the amount or flowof air to the respective pneumatic air chambers. While air is an examplefluid used in the pneumatic decompression described herein, othersuitable fluids can be used to increase or decrease the volume of thebladders, including using liquids in some embodiments. In someembodiments, a two pump system can be employed to alternate or unevenlyinflate the pneumatic air chambers. In some embodiments, a singlecomplex multi-vectored cell or bladder can be used in place of twoindividual cells.

According to one embodiment, by way of example, a frame 112 of atraction device 110 defines a spacing of about nine inches between thecurved side members 122 and 124 at a wide portion with the side memberscoming together at the apex 126 of the frame. The frame 112 ispreferably between about 11 to 17 inches in length in some embodiments.The frame 112 preferably elevates the neck support 128 about 0.5 toabout 1. 5 inches above the floor or surface. In such a configuration,the frame 112 preferably bears against the floor or surface during useand reduces the tendency of the frame to twist about its transverseaxis. The cradle 138 in neck support 128 preferably tapers from anelevation of about 3 inches above the floor proximate side members 122and 124 to a central elevation of about 2.5 inches.

The first expandable bladder 116 is preferably coupled to and carried bythe neck support 128 in the cradle 138 defined therein. The firstexpandable bladder 116 is preferably secured in place as will bedescribed further herein. The lateral portions 134 and 136 of necksupport 128 are preferably provided with oppositely facing recessesformed therein adjacent the lateral ends of cradle 138 for receiving theextended ends of the first expandable bladder 116 to facilitateretention and alignment of the bladder on the cradle 138.

According to some embodiments, the upper portion of the first expandablebladder 116 is of a generally semi-ellipsoidal configuration havingrelatively pointed ends similar to the upper half of a football bladder.In one preferred bladder configuration, the underside of the firstexpandable bladder 116 is formed with undercut portions so as to definea central depending portion. At least a portion of the cradle ispreferably configured to receive the underside of the first expandablebladder 116. Preferably, the first expandable bladder 116, wheninflated, will expand upwardly from the cradle 138 to a slightly greaterextent than in a transverse direction. Additionally, in someembodiments, provision of the depending portion on the underside of thebladder provides a cushioning effect under the apex of the expandedbladder which bears against the user's neck, making the device morecomfortable for the user. Thus, as the bladder is inflated under andagainst the user's neck, it expands vertically and transversely, liftingthe spine to create a spinal apex and applying an angular traction tothe neck on both sides of the spinal apex. The amount of tractionexerted in the vertical direction, however, will be somewhat greaterthan that exerted longitudinally to obtain the vertical lift necessaryto restore the normal lordotic shape to the cervical region of the spinewithout overly tractioning the neck longitudinally.

In some embodiments, the first inflatable bladder 116 is constructed ofan expandable material such as neoprene rubber, defines a length ofbetween about 8 to 10 inches, a height of about 3 to 4 inches in anuninflated state, and depending on the configuration of the bladder atransverse width of about 3 inches. In some embodiments, the bladder 116is constructed of a material that resists expansion. In someembodiments, the bladder 116 is constructed of a heat-sealable urethanewith 200 Denier nylon. The bladder 116 can comprise a cover of anysuitable material, including, for example, a neoprene material. Thesemi-ellipsoidal upper portion of the first inflatable bladder 116, wheninflated, defines a transverse arc of about 4 inches in length about thecenter of the bladder. It is to be understood that these dimensions areby way of example only and can be varied, as can the configuration ofthe frame, straps, and first and second bladders without departing fromthe spirit and scope of the invention. For example, in some embodimentsthe bladder 116 can have a length of between about 6 to 9 inches, aheight of about 2 to 3 inches in a deflated state, a height of about 3to 4 inches in an inflated state. In some embodiments a deflatedcircumference of the bladder is about 4 inches and an inflatedcircumference of the bladder is between about 7 and 8 inches. In aninflated configuration, the bladder 116 can be taller than it is wide,for example, it can be approximately 4 inches tall and approximately 3inches wide when inflated in some embodiments.

The second expandable bladder 118 is coupled to and carried by the necksupport 128. The second expandable bladder 118 is preferably adjustablein some embodiments to accommodate patient anatomy and align withdesired force vector directions as will be described further herein. Thelateral portions 134 and 136 of neck support 128 are preferablyconfigured with recesses formed therein for receiving the extended ends148, shown in FIG. 7, of the second expandable bladder 118 to facilitateretention and alignment of the bladder on the neck support 128.

According to some embodiments, the second expandable bladder 118 is of agenerally semi-ellipsoidal configuration having a relatively curvedportion upon inflation for engaging a portion of the thoracic spine.Preferably, the second expandable bladder 118, when inflated, willexpand about the same amount transversely and upwardly from the necksupport 128. In some embodiments, the second expandable bladder 118 wheninflated expands more transversely than upwardly. In some embodiments,the second expandable bladder 118 when inflated expands more upwardlythan transversely. Thus, as the second expandable bladder 118 isinflated under and against the user's thoracic spine, it expandstransversely and vertically, lifting the spine to counter hyper-kyphosisand applying an angular traction to the thoracic spine. The amount oftraction exerted in the longitudinal direction, preferably, will besimilar to the amount of lift exerted vertically to obtain the necessarydecompression and lift to restore the normal shape to the thoracicregion of the spine.

In some embodiments, the second inflatable bladder 118 is constructed ofan expandable material such as neoprene rubber, defines a length ofbetween about 8 to 10 inches, a height of about 3 to 4 inches in anuninflated state, and depending on the configuration of the bladder atransverse width of about 3 inches. In some embodiments, the bladder 118is constructed of a material that resists expansion. In someembodiments, the bladder 118 is constructed of a heat-sealable urethanewith 200 Denier nylon. The bladder 118 can comprise a cover of anysuitable material, including, for example, a neoprene material. Thesecond inflatable bladder 118, when inflated, defines a transverse arcof about 4 inches in length about the center of the bladder. It is to beunderstood that these dimensions are by way of example only and can bevaried without departing from the spirit and scope of the invention. Forexample, in some embodiments the bladder 118 can have a length of about9 inches where it is coupled to the frame, a length of between about 6and 7 inches where the bladder 118 contacts the patient. The bladder 118can have a height of about 3 to 4 inches. The bladder 118 can have acircumference of about 6 to 7 inches.

In some embodiments the bladders preferably have a finite shape andexpand while being filled until the bladders reach the finite shape.Once the bladder has been filled to the finite shape, the pressurerelease valve of the pump assembly allows for gas or fluid to escapefrom the system to maintain a desired pressure within the bladder. Thepressure release valve is preferably an automatic pressure releasevalve. The system preferably also comprises a manual release valve, suchas a push button release valve. The desired pressure is preferably heldat a proven clinical level. In some embodiments the pressure releasevalve is configured to maintain a pressure of about 8 psi. At a pressureof about 8 psi the system preferably provides over 50 pounds oftractional force. In some embodiments the tractional force preferably isbetween about 50 and 60 pounds of tractional force.

While the above described bladder configurations are preferred, it is tobe understood that other configurations of expandable bladders could beemployed in the present invention, either with or without an expansioncontrolling casing to provide the desired lifting and traction of theuser's neck and spine. Moreover, in some embodiments, mechanicallyexpandable components can be used in place of the first and secondbladders. Mechanically expandable components can be coupled to the frameand selectively expanded to apply force vectors to the cervical andthoracic spine in a manner similar to those produced by the expandablebladders as described herein. For example, in some embodiments anexpanding mechanical component within a cushioned cover can beselectively actuated to provide the desired force distribution.

In some embodiments, one or more of the first and second expandablebladders 116, 118 are of a tubular configuration and are disposed in anon-expandable casing, preferably constructed of a vinyl or othersuitable material. The casing is preferably formed in the abovedescribed generally ellipsoidal configurations. As the tubular bladderexpands upon inflation, the expansion is limited by the configuration ofthe casing to provide the desired increase in the vertical andtransverse directions.

In some embodiments, as shown in FIG. 8, the first expandable bladder116 is preferably rotatably secured to the neck support 128. The firstexpandable bladder 116 can be tilted in a forward position, a backwardposition, or maintained in a central position. In some embodiments, thebladder can be locked into a desired position. Providing a rotatablefirst expandable bladder 116 preferably provides mobility for thepneumatic air chamber to comfortably accommodate various spinalconfigurations. In some embodiments, the second expandable bladder 118can be rotatably secured to the neck support 128.

In some embodiments, as shown in FIGS. 8 and 9, a spacer component 150is preferably configured to be selectively coupled to the frame 112 toadjust a position of a second inflatable bladder 118. The spacercomponent can be attached to the frame and can allow clinicians andusers to increase the negative Y directional component of the lowerpneumatic air chamber. In one embodiment, the spacer component comprisesan pneumatic air chamber or bladder engaging face 152, a notchedconnector portion 154 and opposing side portions 156. Other spacerconfigurations can be used to modify the directional component of thesecond inflatable bladder 118.

FIGS. 10A-F are illustrative views of a patient's spine in multipleconfigurations, including some embodiments of decompression and tractionsystems in use in deflated and inflated configurations. FIG. 10A shows apatient with cervical curve loss, forward head carriage, and disccompression. FIG. 10B shows a patient with normal spinal curves. FIGS.10C and 10D show a patient and one embodiment of a decompression system110 having a chin and forehead restraint, wherein the views show thedecompression system 110 in a deflated configuration and an inflatedconfiguration, respectively. FIGS. 10E and 10F show a patient andanother embodiment of a decompression system 110 having a foreheadrestraint, wherein the views show the decompression system 110 in adeflated configuration and an inflated configuration, respectively.

As shown in FIGS. 10C-F, restraint straps 158 and/or 160 can be securedat the ends thereof to one or more of slots 114. Straps can be passedunder the user's chin and over the user's forehead in some embodiments.In other embodiments, a strap can be passed over the user's foreheadonly. The straps can be secured and fastened in any suitable manner. Forexample, interlocking hook and loop type fasteners, snaps, buckles orother fasteners can be used. According to some embodiments, the tractiondevice 110 can be easily and securely affixed to the user's head with astrap configuration such that with the user lying flat on his or herback on a horizontal surface, the frame 112 rests on the surface and theneck support 128 is disposed under the user's neck and tapered ends 162of the frame side members 122, 124 are substantially adjacent the user'sshoulders and generally near the upper thoracic region. The tightness ofthe securement of the device 110 to the user's head can be readilyadjusted as needed by the securement straps 158, 160.

In some embodiments, the system preferably comprises a frame made ofvirgin acrylonitrile butadiene styrene (ABS) plastic material. ABS is anengineering thermoplastic that is advantageous due to its strength,toughness, chemical resistance, and ability to maintain necessarystiffness. The expandable pneumatic air chambers are preferably made ofheat-sealable urethane with 200 Denier nylon. The expandable pneumaticair chambers preferably have a neoprene cover. The facial straps arepreferably made of a durable and waterproof neoprene material. The handpump and tubing are preferably made of rubber/plastic. Other embodimentscan include different materials.

According to some embodiments, the system is lightweight (for example,about 3 lbs), portable, easy to operate, requires no assembly, noweights, cables or ropes to set-up, comes with choice of ballistic nyloncarrying case or educational box, instruction page and instructionalDVD. In one embodiment, the device comprises a built-in frame, anexpanding elliptical pneumatic air chamber (with neoprene cover) thatcreates radial tractional force and thoracic decompressive force, apatient-controlled pneumatic hand pump with a push button release andautomatic safety valve connected to approximately 30 inches of tubing,and one dual action head restraint designed for patients who suffer withTMJ (does not aggravate temporomandibular joint), which comprises anadjustable forehead strap, and a removable chin strap (which is optionalin some other embodiments).

Accordingly to one aspect disclosed herein, methods for pneumatic radialtraction can restore the cervical and thoracic spine to the properconfiguration. Pneumatic radial traction, also known in some embodimentsas expanding ellipsoidal decompression (EED), is a process in whichjoints of the cervical spine are pneumatically tractioned andsimultaneously aligned into the cervical spine's proper radial or curvedconfiguration. A major clinical difference between some embodiments of apneumatic radial traction device disclosed herein and some prior artdevices is that the prior art devices flatten or reverse the propercervical curve to attain joint separation. In some embodiments, apneumatic radial traction device enhances or maintains the propercervical curve while attaining over twice the joint separation as someprior art devices.

With reference to FIGS. 10A and 10B, in the upright position, thecervical “lordotic” curve is what allows the weight of the head (10-15lbs.) to be directed toward the hard boney posterior articular surfacesof the neck rather than toward the softer anterior discs as in thecompressed neck. Through modern healthcare imaging it can be seen thatthat loss of the normal forward cervical curve (approx.43°) and theresulting anterior disc compression this causes, was a contributingfactor in osteophyte formation (Wolff's Law), posterior disc bulging,disc herniation, disc degeneration, neck pain and loss in cervical rangeof motion.

With reference to FIGS. 10C to 10F, pneumatic radial traction separatesand simultaneously aligns the spinal joints in a curved or radialconfiguration. In some embodiments, an elliptical pneumatic air chamberdirects multi-vectored expansive forces from within the posterior spinalconcavity (back of neck), vertically (+Z axis translation) and in bothhorizontal directions. The spine is simultaneously tractioned in threemain directions. The radial configuration created by thesemulti-vectored forces produces high level joint separation at theposterior, middle and anterior of the disc while forcefully enhancingthe cervical spine's proper curve, rather than flattening or reversingthe curve. Pneumatic radial traction is preferably achieved when thejoints are separated by a vertical displacement greater than thehorizontal displacement, however, displacement of equal height and widthis also advantageous in some embodiments. An advantage of a pneumaticradial traction device is that it does not flatten or reverse the propercervical curve while attaining joint separation. In some embodiments,the system provides a traction device with multiple fulcrums. Forexample, at least two fulcrums are provided to provide treatment to thecervical and thoracic spine of the patient.

As the head is stabilized in the cervical device, joints are activelytractioned in 3 main directions instead of one or two. The cervicalspine is tractioned vertically along the +Z axis with a pneumatic forceof over 58 lbs. This force expands into and against the posteriorcervical concavity. Simultaneously the spine is tractioned horizontallyin the two traditional directions (+Y and −Y) with a pneumatic force ofover 40-lbs in each direction. These forces expand against the occiputand against the upper thoracic region. The combination of thesesimultaneously applied pneumatic forces produce radial traction. Whenfully inflated the elliptical pneumatic cell expands to a 7.5 inchradius, affecting the entire cervical spine. High level joint tractionoccurs at the posterior, center and anterior aspect of the vertebralbodies in a ratio coinciding with the discs' natural wedged spacing.While the pneumatic radial traction device separates the posterior ofthe joints to a magnitude typical of traditional traction, it separatesthe overall disc more than twice as much as linear traction.

With the simultaneous application of two separate pneumatic air chambersthe cervical spine is decompressed into its proper lordotic or curvedconfiguration (<{circumflex over ( )}>) with −Y+Z+Y force vectors whilethe hyper kyphotic area of the upper thoracic spine is simultaneouslydecompressed with a combination +Z/−Y force mid-vector. The cervicalspine's lordotic curve is powerfully decompressed and enhanced while thethoracic hyper-kyphosis is simultaneously reduced.

Continuous expansion and contraction of the pneumatic air chambers canbe employed to create alternating hydration and milking of theintervertebral discs, activating their sponge-like imbibition action.Holding the air pressure constant over a period of 15 to 20 minutes hasthe effect of simultaneously molding the spine into a curved orelliptical shape, decompressing discs and relaxing the dura, cord andnerve-roots in the cervical canal.

Embodiments described herein are preferably prescribed for patients withchronic neck pain due to a musculoskeletal or neurological impairment.The system applies radial tractional force to the cervical spine,enhancing the cervical lordotic curve while achieving high level jointseparation at the anterior, center and posterior aspect of the vertebralbodies and discs in a ratio corresponding with their natural wedgedspacing, reducing disc protrusions, compression and increasing range ofmotion. In some applications, devices advantageously decrease pain inchronic neck pain patients, decrease headaches and increase range ofmotion while reducing the necessity for chronic pain medication and necksurgery.

With continued reference to FIGS. 10A-10F, according to some embodimentsin use, the traction device 110 rests on a horizontal surface such thatthe neck support 128 projects upwardly therefrom. The user lies on thedevice in a prone position such that the back of the neck rests on thedeflated first expandable bladder 116 carried in the cradle 138 of theneck support 128. The deflated second expandable bladder 118 ispositioned between the neck support 128 and portions of the thoracicspine of the user. The chin and/or forehead restraining restraint strapsare respectively extended under the user's chin and/or about the user'sforehead and secured, thereby affixing the traction device 110 to theuser such that the neck and cervical spine extend over the neck supportand first expandable bladder 116 and the thoracic spine is adjacent thesecond expandable bladder 118. According to one preferred embodiment,the outward extension of the neck support 128 is relatively slight sothat when the bladder is in the deflated position with the forehead andchin restraints secured, very little or no force is exerted on the neckby the neck support. This is achieved by elevating the neck support 128above the frame such that the neck cradle 138 formed therein is about 2to 3 inches above the floor or other horizontal surface on which thedevice 110 is used. The first expandable bladder 116 is sized such thatupon full inflation, the apex of the curved upper surface of the bladderwill extend about 5 inches above the floor or surface. The secondexpandable bladder 118 is sized such that upon full inflation, a surfaceof the second expandable bladder engaging the thoracic spine will extendtoward the thoracic spine about 2 to 3 inches in the −Y/+Z direction.

In some embodiments, as the user slowly inflates the first and secondinflatable bladders 116, 118 using the air pump 142, the firstinflatable bladder 116 expands upwardly and, to a lesser extent,transversely, thereby forcing the cervical spine forwardly creating aspinal apex while concurrently stretching the spine angularly along bothsides of the formed spinal apex. The second inflatable bladder 118expands transversely in the −Y direction, thereby forcing the thoracicspine forwardly to offset the effects of hyper-khyphosis. The user thencontinues to inflate the first and second bladders 116 and 118 until hisor her individual tolerance level is reached. The bladders are thendeflated by use of the one way valve 144. The process is preferablyrepeated several times, slowly increasing the spinal arc in the cervicalregion and placing pressure on the thoracic region as the level oftolerance increases. In addition, the first and second bladders 116 and118 can be held in an inflated state at or slightly below the level oftolerance for varying periods of time up to ten to twenty minutes.Through such repetition, the cervical spine, thoracic spine andsurrounding tissue receive a workout promoting cellular exchange in andaround the intervertebral disc and a forward curve is reinstated intothe cervical spine while achieving proper spine configuration in thethoracic region. FIGS. 10A-10F illustrate the effects of the tractionand exercise devices 110 of some embodiments on the cervical andthoracic spine.

With reference to FIGS. 11-14, an adjustable spacer component 150 can beprovided in some implementations of a traction system 110 to provide forlateral flexion traction. For example, FIG. 11 is a schematic top viewof a patient positioned on another embodiment of a decompression andtraction system, showing pneumatic air chambers comprising first andsecond inflatable bladders 116, 118 and an adjustable wedge-shapedspacer component 150 configured to be selectively coupled to the frameto adjust a position of the second inflatable bladder, in the shownconfiguration the spacer component is in a vertical orientation andadjusts the position of the second inflatable bladder to provide an evendistribution of force generally along a force vector in the −Y and +Zplane without providing any lateral flexion traction to the patient.

FIG. 12 shows a configuration wherein the spacer component is moved toadjust the position of the second inflatable bladder to provide anuneven distribution of force on one side of the patient in that a forcevector is directed, for example, in a −Y, +Z, and −X direction. Forexample, the spacer component is turned or rotated to a horizontalposition, whereby the wedge shape of the spacer contacts the secondinflatable bladder and causes the bladder to deflect in one lateraldirection more than another lateral direction. As shown, the spacer isplaced in right horizontal position and causes more deflection on theright side of the patient. In other configurations, the spacer can bepositioned in a left horizontal position to cause more deflection on theleft side of the patient. Based on the positioning of the spacer, thesecond bladder can expand in an angular direction. Turning the spacercomponent sideways creates lateral flexion traction by forcing theshoulder/trapezius down while the head is held in traction.

FIG. 13 is a bottom view of the embodiment of FIG. 11 and shows thespacer component in a vertical position that adjusts the position of thesecond inflatable bladder to provide an even distribution of forcegenerally along a force vector in the −Y and +Z plane, but does notdirect force laterally in a −X or +X direction. FIG. 14 is a bottom viewof the embodiment of FIG. 11, showing a configuration wherein the spacercomponent is moved to adjust the position of the second inflatablebladder to provide an uneven distribution of force to a patient in thata force vector is directed, for example, in a −Y, +Z, and −X directionas described in connection with FIG. 12. The lower linear displacementpneumatic air chamber is adjusted with a rotating wedge shaped spacercomponent, allowing clinicians to increase the angle and force of themid (−Y)/(+Z) vector of this pneumatic air chamber. When adjusted to theright or left horizontal position, the rotating wedge allows cliniciansto unilaterally increase and rotate the (−Y) directional component oneither the right or left side (+/−X) of the upper thoracic region,producing lateral flexion traction. The rotating wedge shaped spacercomponent can be removed in some implementations to accommodate extremekyphotic thoracic spines.

In some embodiments, the device comprises a frame, a first substantiallyellipsoidal inflatable bladder transversely in a neck support cradlecarried by the frame, a second inflatable bladder supported on the necksupport cradle carried by the frame and configured to provide a forcevector against the upper thoracic spine when inflated, a thirdinflatable bladder supported on the neck support cradle carried by theframe and configured to provide a force vector against the occiput wheninflated, one or more restraining straps for securing the device to theuser's head such that the first and second bladders are disposed againstthe back of the neck under a stress point in the cervical spine andagainst the hyper-kyphotic upper thoracic spine, respectively.Controlled inflation of the bladders by the user by a hand-held pumpcauses a controlled lifting and a stretching of the cervical andthoracic spine and decompression of the occipital-cervical junction. Asthe first bladder is inflated, the configuration of the first bladdercauses the first bladder to expand vertically and, to a lesser extent,transversely. The vertical expansion lifts the spine, creating a spinalapex while the transverse expansion of the bladder applies an angulartraction to the neck on both sides of the apex. As the second bladder isinflated, preferably simultaneously, the configuration of the secondbladder causes the second bladder to expand vertically and transversely.The vertical and transverse expansion lifts the spine and applies anangular traction to the thoracic region. As the third bladder isinflated, preferably simultaneously, the configuration of the thirdbladder causes the third bladder to expand vertically and transversely.The vertical and transverse expansion lifts the head and applies anangular traction to the occiput.

By controlling the inflation of the bladders, the user can control thelifting and stretching of the spine and incrementally increase themagnitude of spinal arc and decompression of the cervical region,thoracic region, and occipital-cervical junction to his or her owntolerance. As the bladders are repetitively inflated to the tolerance ofthe user and deflated, the cervical spine is alternatively and activelyforced from a lesser arc to a greater or hyper-lordotic arc, thehyper-kyphotic arc of the upper thoracic spine is simultaneously reducedand decompressed, and the occipital-cervical junction is simultaneouslydecompressed, thereby promoting nutrient transport to the intervertebraldiscs while simultaneously increasing the cervical lordotic arc anddecreasing the thoracic hyper-kyphosis. These decompression and tractionsystems and related methods are described in greater detail below.

Referring now to the drawings, as shown in FIGS. 15-19, according to oneembodiment, a traction device 210 comprises the frame 112, openings orslots 114 configured to receive one or more straps to restrain theforehead and/or chin of a user, the first inflatable air bladder 116,the second inflatable air bladder 118, a third inflatable bladder 119,and an air pump assembly 120.

The frame 112 is preferably molded of a durable plastic material in atubular configuration so as to define a pair of side members 122 and 124curved and meeting at an apex 126, and a transverse neck support 128.The frame side members 122 and 124 preferably form a stable base. Theneck support 128 preferably comprises vertically extending portions 130and 132 which project upwardly from the side members 122 and 124respectively and project inwardly to define inwardly directed raisedlateral portions 134 and 136. A neck cradle 138 extends transverselybetween portions 134 and 136, spanning frame side members 122 and 124.In some embodiments, the frame can be provided with side members thatare not connected at an apex 126, such as in some embodiments where sidemembers are shorter.

The first, second, and third air bladders 116, 118, and 119 arepreferably configured for inflation and simultaneous application offorce to the cervical spine, the thoracic spine, and the occiput, whenthe patient is in a treatment position, to decompress the spine into itsproper lordotic or curved configuration (<{circumflex over ( )}>) with−Y+Z+Y force vectors being applied to the cervical spine while thehyper-kyphotic area of the upper thoracic spine is simultaneouslydecompressed with a combination +Z/−Y force mid-vector and +Z/+Y forcevectors are applied to the occiput to decompress the occipital-cervicaljunction. The cervical spine's lordotic curve is powerfully decompressedand enhanced while the thoracic hyper-kyphosis is simultaneouslyreduced. In some embodiments, the devices, systems and methods describedherein use the entire cervical spine as a first anchor point, the upperthoracic spine as a second point, and the occiput as a third anchorpoint. The pneumatic air chambers can directly contact the cervicalspine, the upper 25%-40% of the thoracic spine, and the occiput. Thefirst, second, and third inflatable bladders 116, 118, and 119 aredescribed in more detail below.

To provide selective inflation and deflation of the first, second, andthird inflatable bladders 116, 118, and 119, a flexible air line 140 ofthe air pump assembly 120 communicates the interior of the first,second, and third inflatable bladders 116, 118, and 119 with ahand-operated air pump 142. In other embodiments an automated pump orelectronic pump can be used. The electronic pump may be part of anelectronic pump system. In certain embodiments, the electronic pumpsystem can include a processor configured to execute one or moresoftware applications that cause the electronic pump to fill one or moreof the first, second, and third inflatable bladders 116, 118, and 119.In certain embodiments, the electronic pump can be configured to inflateone or more of the first, second, and third inflatable bladders 116,118, and 119 to one or more predefined or user selected inflationamounts. For example, in some embodiments, the software applicationsallow for selective inflation of one or more of the first, second, andthird inflatable bladders 116, 118, and 119 to low, medium, and/or highamounts of inflation. In certain embodiments, the electronic pump systemcan include a user interface that allows a user to select and/or controlone or more settings of the pump. For example, the user interface canallow for a selection of one or more of the first, second, and thirdinflatable bladders 116, 118, and 119 for inflation. In someembodiments, the user interface can allow for a selection of one or moreinflation amounts for each inflatable bladder. In certain embodiments,the user interface can be provided on the electronic pump. In someembodiments, the user interface can be provided on an external device.

A pressure relief valve 144 is preferably disposed between the air line140 and pump 142. Air line 140 preferably extends from the relief valve144 through an opening in the neck support 128 and communicates with thefirst and second inflatable bladders 116, 118. In some embodiments, theair can be communicated through openings formed in the underside or endsof the bladders. In some embodiments, a valve 246, such as amulti-directional metering valve, shown in FIGS. 19 and 20 for example,can be coupled with the air line 140 and can direct air to the first,second, and third inflatable bladders 116, 118, and 119. In someembodiments the valve 246 comprises different lumen diameters to varythe air flow directed to the opposing traction pneumatic air chambers ofthe first, second, and third inflatable bladders 116, 118, and 119.Different valve components can be used to adjust the amount or flow ofair to the respective pneumatic air chambers. While air is an examplefluid used in the pneumatic decompression described herein, othersuitable fluids can be used to increase or decrease the volume of thebladders, including using liquids in some embodiments. In someembodiments, a two pump system or a three pump system can be employed toalternate or unevenly inflate the pneumatic air chambers. For example,in some embodiments, a first pump can be employed to inflate the firstinflatable bladder 116 and a second pump can be employed to inflate thesecond and third inflatable bladders 118 and 119. In some embodiments, afirst pump can be employed to inflate the first and second inflatablebladders 116 and 118 and a second pump can be employed to inflate thethird inflatable bladder 119. In some embodiments, a pump can beemployed to inflate the first and third inflatable bladders 116 and 119and a second pump can be employed to inflate the second inflatablebladder 118. In some embodiments, a single complex multi-vectored cellor bladder can be used in place of three individual cells. In someembodiments, a single complex multi-vectored cell or bladder can be usedin place of two of three inflatable bladders 116, 118, and 119. Forexample, in some embodiments, a single complex multi-vectored cell orbladder can be used in place of the first and second inflatable bladders116 and 118. In some embodiments, a single complex multi-vectored cellor bladder can be used in place of the first and third inflatablebladders 116 and 119.

According to one embodiment, by way of example, a frame 112 of atraction device 110 defines a spacing of about nine inches between thecurved side members 122 and 124 at a wide portion with the side memberscoming together at the apex 126 of the frame. The frame 112 ispreferably between about 11 to 17 inches in length in some embodiments.The frame 112 preferably elevates the neck support 128 about 0.5 toabout 1. 5 inches above the floor or surface. In such a configuration,the frame 112 preferably bears against the floor or surface during useand reduces the tendency of the frame to twist about its transverseaxis. The cradle 138 in neck support 128 preferably tapers from anelevation of about 3 inches above the floor proximate side members 122and 124 to a central elevation of about 2.5 inches.

The first expandable bladder 116 is preferably coupled to and carried bythe neck support 128 in the cradle 138 defined therein. The firstexpandable bladder 116 is preferably secured in place as will bedescribed further herein. The lateral portions 134 and 136 of necksupport 128 are preferably provided with oppositely facing recessesformed therein adjacent the lateral ends of cradle 138 for receiving theextended ends of the first expandable bladder 116 to facilitateretention and alignment of the bladder on the cradle 138.

According to some embodiments, the upper portion of the first expandablebladder 116 is of a generally semi-ellipsoidal configuration havingrelatively pointed ends similar to the upper half of a football bladder.In one preferred bladder configuration, the underside of the firstexpandable bladder 116 is formed with undercut portions so as to definea central depending portion. At least a portion of the cradle ispreferably configured to receive the underside of the first expandablebladder 116. Preferably, the first expandable bladder 116, wheninflated, will expand upwardly from the cradle 138 to a slightly greaterextent than in a transverse direction. Additionally, in someembodiments, provision of the depending portion on the underside of thebladder provides a cushioning effect under the apex of the expandedbladder which bears against the user's neck, making the device morecomfortable for the user. Thus, as the bladder is inflated under andagainst the user's neck, it expands vertically and transversely, liftingthe spine to create a spinal apex and applying an angular traction tothe neck on both sides of the spinal apex. The amount of tractionexerted in the vertical direction, however, will be somewhat greaterthan that exerted longitudinally to obtain the vertical lift necessaryto restore the normal lordotic shape to the cervical region of the spinewithout overly tractioning the neck longitudinally.

In some embodiments, the first inflatable bladder 116 is constructed ofan expandable material such as neoprene rubber, defines a length ofbetween about 8 to 10 inches, a height of about 3 to 4 inches in anuninflated state, and depending on the configuration of the bladder atransverse width of about 3 inches. In some embodiments, the bladder 116is constructed of a material that resists expansion. In someembodiments, the bladder 116 is constructed of a heat-sealable urethanewith 200 Denier nylon. The bladder 116 can comprise a cover of anysuitable material, including, for example, a neoprene material. Thesemi-ellipsoidal upper portion of the first inflatable bladder 116, wheninflated, defines a transverse arc of about 4 inches in length about thecenter of the bladder. It is to be understood that these dimensions areby way of example only and can be varied, as can the configuration ofthe frame, straps, and first and second bladders without departing fromthe spirit and scope of the invention. For example, in some embodimentsthe bladder 116 can have a length of between about 6 to 9 inches, aheight of about 2 to 3 inches in a deflated state, a height of about 3to 4 inches in an inflated state. In some embodiments a deflatedcircumference of the bladder is about 4 inches and an inflatedcircumference of the bladder is between about 7 and 8 inches. In aninflated configuration, the bladder 116 can be taller than it is wide,for example, it can be approximately 4 inches tall and approximately 3inches wide when inflated in some embodiments.

The second expandable bladder 118 is coupled to and carried by the necksupport 128. The second expandable bladder 118 is preferably adjustablein some embodiments to accommodate patient anatomy and align withdesired force vector directions as will be described further herein. Thelateral portions 134 and 136 of neck support 128 are preferablyconfigured with recesses formed therein for receiving the extended ends148, for example, as described with respect to FIG. 7, of the secondexpandable bladder 118 to facilitate retention and alignment of thebladder on the neck support 128.

According to some embodiments, the second expandable bladder 118 is of agenerally semi-ellipsoidal configuration having a relatively curvedportion upon inflation for engaging a portion of the thoracic spine.Preferably, the second expandable bladder 118, when inflated, willexpand about the same amount transversely and upwardly from the necksupport 128. In some embodiments, the second expandable bladder 118 wheninflated expands more transversely than upwardly. In some embodiments,the second expandable bladder 118 when inflated expands more upwardlythan transversely. Thus, as the second expandable bladder 118 isinflated under and against the user's thoracic spine, it expandstransversely and vertically, lifting the spine to counter hyper-kyphosisand applying an angular traction to the thoracic spine. The amount oftraction exerted in the longitudinal direction, preferably, will besimilar to the amount of lift exerted vertically to obtain the necessarydecompression and lift to restore the normal shape to the thoracicregion of the spine.

In some embodiments, the second inflatable bladder 118 is constructed ofan expandable material such as neoprene rubber, defines a length ofbetween about 8 to 10 inches, a height of about 3 to 4 inches in anuninflated state, and depending on the configuration of the bladder atransverse width of about 3 inches. In some embodiments, the bladder 118is constructed of a material that resists expansion. In someembodiments, the bladder 118 is constructed of a heat-sealable urethanewith 200 Denier nylon. The bladder 118 can comprise a cover of anysuitable material, including, for example, a neoprene material. Thesecond inflatable bladder 118, when inflated, defines a transverse arcof about 4 inches in length about the center of the bladder. It is to beunderstood that these dimensions are by way of example only and can bevaried without departing from the spirit and scope of the invention. Forexample, in some embodiments the bladder 118 can have a length of about9 inches where it is coupled to the frame, a length of between about 6and 7 inches where the bladder 118 contacts the patient. The bladder 118can have a height of about 3 to 4 inches. The bladder 118 can have acircumference of about 6 to 7 inches.

The third expandable bladder 119 is coupled to and carried by the necksupport 128. The third expandable bladder 119 is preferably adjustablein some embodiments to accommodate patient anatomy and align withdesired force vector directions as will be described further herein. Thelateral portions 134 and 136 of neck support 128 are preferablyconfigured with recesses formed therein for receiving the extended ends149, shown in FIG. 21, of the third expandable bladder 119 to facilitateretention and alignment of the bladder on the neck support 128.

According to some embodiments, the third expandable bladder 119 is of agenerally semi-ellipsoidal configuration having a relatively curvedportion upon inflation for engaging a portion of the thoracic spine.Preferably, the third expandable bladder 119, when inflated, will expandabout the same amount transversely and upwardly from the neck support128. In some embodiments, the third expandable bladder 119 when inflatedexpands more transversely than upwardly. In some embodiments, the thirdexpandable bladder 119 when inflated expands more upwardly thantransversely. Thus, as the third expandable bladder 119 is inflatedunder and against the user's occiput, it expands transversely andvertically, lifting the occiput to apply an angular traction to theocciput. The amount of traction exerted in the longitudinal direction,preferably, will be similar to the amount of lift exerted vertically todecompress the occipital-cervical junction.

In some embodiments, the third inflatable bladder 119 is constructed ofan expandable material such as neoprene rubber, defines a length ofbetween about 8 to 10 inches, a height of about 3 to 4 inches in anuninflated state, and depending on the configuration of the bladder atransverse width of about 3 inches. In some embodiments, the bladder 119is constructed of a material that resists expansion. In someembodiments, the bladder 119 is constructed of a heat-sealable urethanewith 200 Denier nylon. The bladder 119 can comprise a cover of anysuitable material, including, for example, a neoprene material. Thethird inflatable bladder 119, when inflated, defines a transverse arc ofabout 4 inches in length about the center of the bladder. It is to beunderstood that these dimensions are by way of example only and can bevaried without departing from the spirit and scope of the invention. Forexample, in some embodiments the bladder 119 can have a length of about9 inches where it is coupled to the frame, a length of between about 6and 7 inches where the bladder 119 contacts the patient. The bladder 119can have a height of about 3 to 4 inches. The bladder 119 can have acircumference of about 6 to 7 inches.

In some embodiments the bladders preferably have a finite shape andexpand while being filled until the bladders reach the finite shape.Once the bladder has been filled to the finite shape, the pressurerelease valve of the pump assembly allows for gas or fluid to escapefrom the system to maintain a desired pressure within the bladder. Thepressure release valve is preferably an automatic pressure releasevalve. The system preferably also comprises a manual release valve, suchas a push button release valve. The desired pressure is preferably heldat a proven clinical level. In some embodiments the pressure releasevalve is configured to maintain a pressure of about 8 psi. At a pressureof about 8 psi the system preferably provides over 50 pounds oftractional force. In some embodiments the tractional force preferably isbetween about 50 and 60 pounds of tractional force.

While the above described bladder configurations are preferred, it is tobe understood that other configurations of expandable bladders could beemployed in the present invention, either with or without an expansioncontrolling casing to provide the desired lifting and traction of theuser's neck, spine, and head. Moreover, in some embodiments,mechanically expandable components can be used in place of the first,second, and/or third bladders. Mechanically expandable components can becoupled to the frame and selectively expanded to apply force vectors tothe cervical and thoracic spine in a manner similar to those produced bythe expandable bladders as described herein. For example, in someembodiments an expanding mechanical component within a cushioned covercan be selectively actuated to provide the desired force distribution.

In some embodiments, one or more of the first, second, and thirdexpandable bladders 116, 118, and 119 are of a tubular configuration andare disposed in a non-expandable casing, preferably constructed of avinyl or other suitable material. The casing is preferably formed in theabove described generally ellipsoidal configurations. As the tubularbladder expands upon inflation, the expansion is limited by theconfiguration of the casing to provide the desired increase in thevertical and transverse directions.

In some embodiments, as shown in FIG. 22, the first expandable bladder116 is preferably rotatably secured to the neck support 128. The firstexpandable bladder 116 can be tilted in a forward position, a backwardposition, or maintained in a central position. In some embodiments, thebladder can be locked into a desired position. Providing a rotatablefirst expandable bladder 116 preferably provides mobility for thepneumatic air chamber to comfortably accommodate various spinalconfigurations. In some embodiments, the second expandable bladder 118can be rotatably secured to the neck support 128. In some embodiments,the third expandable bladder 119 can be rotatably secured to the necksupport 128.

In some embodiments, as shown in FIG. 22, a first spacer component 150Ais preferably configured to be selectively coupled to the frame 112 toadjust a position of a second inflatable bladder 118. The spacercomponent can be attached to the frame and can allow clinicians andusers to increase the negative Y directional component of the lowerpneumatic air chamber. A second spacer component 150B is preferablycoupled to the frame 112 to adjust a position of the third inflatablebladder 119. The spacer component can be attached to the frame and canallow clinicians and users to increase the positive Y direction of theupper pneumatic air chamber. Each of the spacer components 150A and 150Bcan include the same or generally similar features as the spacercomponent 150 described with respect to FIGS. 8 and 9. For example, inone embodiment, each spacer component comprises an pneumatic air chamberor bladder engaging face 152, a notched connector portion 154 andopposing side portions 156. Other spacer configurations can be used tomodify the directional component of the second inflatable bladder 118and the third inflatable bladder 119.

FIGS. 23A and 23B show a patient and an embodiment of a decompressionand traction system 210 having a forehead restraint, wherein the viewsshow the decompression system 210 in an inflated configuration,respectively.

As shown in FIGS. 23A and 23B, restraint straps 158 and/or 160 can besecured at the ends thereof to one or more of slots 114. Straps can bepassed under the user's chin and over the user's forehead in someembodiments. In other embodiments, a strap can be passed over the user'sforehead only. The straps can be secured and fastened in any suitablemanner. For example, interlocking hook and loop type fasteners, snaps,buckles or other fasteners can be used. According to some embodiments,the traction device 210 can be easily and securely affixed to the user'shead with a strap configuration such that with the user lying flat onhis or her back on a horizontal surface, the frame 112 rests on thesurface and the neck support 128 is disposed under the user's neck andtapered ends 162 of the frame side members 122, 124 are substantiallyadjacent the user's shoulders and generally near the upper thoracicregion. The tightness of the securement of the device 110 to the user'shead can be readily adjusted as needed by the securement straps 158,160.

In some embodiments, the system preferably comprises a frame made ofvirgin acrylonitrile butadiene styrene (ABS) plastic material. ABS is anengineering thermoplastic that is advantageous due to its strength,toughness, chemical resistance, and ability to maintain necessarystiffness. The expandable pneumatic air chambers are preferably made ofheat-sealable urethane with 200 Denier nylon. The expandable pneumaticair chambers preferably have a neoprene cover. The facial straps arepreferably made of a durable and waterproof neoprene material. The handpump and tubing are preferably made of rubber/plastic. Other embodimentscan include different materials.

According to some embodiments, the system is lightweight (for example,about 3 lbs), portable, easy to operate, requires no assembly, noweights, cables or ropes to set-up, comes with choice of ballistic nyloncarrying case or educational box, instruction page and instructionalDVD. In one embodiment, the device comprises a built-in frame, anexpanding elliptical pneumatic air chamber (with neoprene cover) thatcreates radial tractional force and thoracic decompressive force, apatient-controlled pneumatic hand pump with a push button release andautomatic safety valve connected to approximately 30 inches of tubing,and one dual action head restraint designed for patients who suffer withTMJ (does not aggravate temporomandibular joint), which comprises anadjustable forehead strap, and a removable chin strap (which is optionalin some other embodiments).

Accordingly to one aspect disclosed herein, methods for pneumatic radialtraction can restore the cervical and thoracic spine to the properconfiguration. Pneumatic radial traction, also known in some embodimentsas expanding ellipsoidal decompression (EED), is a process in whichjoints of the cervical spine are pneumatically tractioned andsimultaneously aligned into the cervical spine's proper radial or curvedconfiguration. A major clinical difference between some embodiments of apneumatic radial traction device disclosed herein and some prior artdevices is that the prior art devices flatten or reverse the propercervical curve to attain joint separation. In some embodiments, apneumatic radial traction device enhances or maintains the propercervical curve while attaining over twice the joint separation as someprior art devices.

With reference to FIGS. 23A and 23B, pneumatic radial traction separatesand simultaneously aligns the spinal joints in a curved or radialconfiguration. In some embodiments, an elliptical pneumatic air chamberdirects multi-vectored expansive forces from within the posterior spinalconcavity (back of neck), vertically (+Z axis translation) and in bothhorizontal directions. The spine is simultaneously tractioned in threemain directions. The radial configuration created by thesemulti-vectored forces produces high level joint separation at theposterior, middle and anterior of the disc while forcefully enhancingthe cervical spine's proper curve, rather than flattening or reversingthe curve. Pneumatic radial traction is preferably achieved when thejoints are separated by a vertical displacement greater than thehorizontal displacement, however, displacement of equal height and widthis also advantageous in some embodiments. An advantage of a pneumaticradial traction device is that it does not flatten or reverse the propercervical curve while attaining joint separation. In some embodiments,the system provides a traction device with multiple fulcrums. Forexample, at least two fulcrums, and preferably three fulcrums, areprovided to provide treatment to the cervical spine, thoracic spine, andoccipital-cervical junction of the patient.

As the head is stabilized in the cervical device, joints are activelytractioned in 3 main directions instead of one or two. The cervicalspine is tractioned vertically along the +Z axis with a pneumatic forceof over 58 lbs. This force expands into and against the posteriorcervical concavity. Simultaneously the spine is tractioned horizontallyin the two traditional directions (+Y and −Y) with a pneumatic force ofover 40-lbs in each direction. These forces expand against the occiputand against the upper thoracic region. The combination of thesesimultaneously applied pneumatic forces produce radial traction. Whenfully inflated the elliptical pneumatic cell expands to a 7.5 inchradius, affecting the entire cervical spine. High level joint tractionoccurs at the posterior, center and anterior aspect of the vertebralbodies in a ratio coinciding with the discs' natural wedged spacing.While the pneumatic radial traction device separates the posterior ofthe joints to a magnitude typical of traditional traction, it separatesthe overall disc more than twice as much as linear traction.

With the simultaneous application of three separate pneumatic airchambers the cervical spine is decompressed into its proper lordotic orcurved configuration (<{circumflex over ( )}>) with −Y+Z+Y force vectorswhile the hyper kyphotic area of the upper thoracic spine issimultaneously decompressed with a combination +Z/−Y force mid-vectorand the occipital-cervical junction is simultaneously decompressed with+Z/+Y force vectors. The cervical spine's lordotic curve is powerfullydecompressed and enhanced while the thoracic hyper-kyphosis issimultaneously reduced and the occipital-cervical junction isdecompressed. In certain embodiments, 15° to 20° of forward head flexioncan be imparted by the application of +Z/+Y force vectors to theocciput.

Continuous expansion and contraction of the pneumatic air chambers canbe employed to create alternating hydration and milking of theintervertebral discs, activating their sponge-like imbibition action.Holding the air pressure constant over a period of 15 to 20 minutes hasthe effect of simultaneously molding the spine into a curved orelliptical shape, decompressing discs and relaxing the dura, cord andnerve-roots in the cervical canal.

Embodiments described herein are preferably prescribed for patients withchronic neck pain due to a musculoskeletal or neurological impairment.The system applies radial tractional force to the cervical spine,enhancing the cervical lordotic curve while achieving high level jointseparation at the anterior, center and posterior aspect of the vertebralbodies and discs in a ratio corresponding with their natural wedgedspacing, reducing disc protrusions, compression and increasing range ofmotion. The system further applies angular traction forces to theocciput, achieving decompression of the occipital-cervical junction. Insome applications, devices advantageously decrease pain in chronic neckpain patients, decrease headaches and increase range of motion whilereducing the necessity for chronic pain medication and neck surgery.

With continued reference to FIGS. 23A and 23B, according to someembodiments in use, the traction device 110 rests on a horizontalsurface such that the neck support 128 projects upwardly therefrom. Theuser lies on the device in a prone position such that the back of theneck rests on the deflated first expandable bladder 116 carried in thecradle 138 of the neck support 128. The deflated second expandablebladder 118 is positioned between the neck support 128 and portions ofthe thoracic spine of the user. The deflated third expandable bladder119 is positioned between the neck support 128 and the occiput of theuser. The chin and/or forehead restraining restraint straps arerespectively extended under the user's chin and/or about the user'sforehead and secured, thereby affixing the traction device 110 to theuser such that the neck and cervical spine extend over the neck supportand first expandable bladder 116, the thoracic spine is adjacent thesecond expandable bladder 118, and the occiput is adjacent the thirdexpandable bladder 119. According to one preferred embodiment, theoutward extension of the neck support 128 is relatively slight so thatwhen the bladder is in the deflated position with the forehead and chinrestraints secured, very little or no force is exerted on the neck bythe neck support. This is achieved by elevating the neck support 128above the frame such that the neck cradle 138 formed therein is about 2to 3 inches above the floor or other horizontal surface on which thedevice 110 is used. The first expandable bladder 116 is sized such thatupon full inflation, the apex of the curved upper surface of the bladderwill extend about 5 inches above the floor or surface. The secondexpandable bladder 118 is sized such that upon full inflation, a surfaceof the second expandable bladder engaging the thoracic spine will extendtoward the thoracic spine about 2 to 3 inches in the −Y/+Z direction. Incertain embodiments, the second expandable bladder 118 is sized and/orpositioned such that during inflation, a surface of the secondexpandable bladder 118 engaging the thoracic spine will impart a forceto the thoracic spine in the −Y direction during a first period ofinflation and will impart a force to the thoracic spine in the −Y/+Zdirection during a second period of inflation following the first periodof inflation. In certain embodiments, the expandable bladder 118 issized and/or positioned such that upon full inflation, a surface of theexpandable bladder 118 engaging the thoracic spine will impart a forceto the thoracic spine in the −Y direction. The third expandable bladder119 is sized such that upon inflation, a surface of the third expandablebladder engaging the occiput will extend toward the occiput about 2 to 3inches in the +Y/+Z direction. Upon inflation, the third expandablebladder 119 can impart 15° to 20° of forward head flexion. In certainembodiments, the third expandable bladder 119 is sized and/or positionedsuch that during inflation, a surface of the third expandable bladder119 engaging the occiput will impart a force to the occiput in the +Ydirection during a first period of inflation and will impart a force tothe occiput in the +Y/+Z direction during a second period of inflationfollowing the first period of inflation. In certain embodiments, theexpandable bladder 119 is sized and/or positioned such that upon fullinflation, a surface of the expandable bladder 119 engaging the occiputwill impart a force to the thoracic spine in the +Y direction.

In some embodiments, as the user slowly inflates the first, second, andthird inflatable bladders 116, 118, and 119 using the air pump 142, thefirst inflatable bladder 116 expands upwardly and, to a lesser extent,transversely, thereby forcing the cervical spine forwardly creating aspinal apex while concurrently stretching the spine angularly along bothsides of the formed spinal apex. The second inflatable bladder 118expands transversely in the −Y direction, thereby forcing the thoracicspine forwardly to offset the effects of hyper-khyphosis. The thirdinflatable platter expands transversely in the +Y direction, therebyforcing the occiput forwardly and upwardly to create radial traction toattain joint separation of the occipital-cervical junction. The userthen continues to inflate the first, second, and third bladders 116,118, and 119 until his or her individual tolerance level is reached. Thebladders are then deflated by use of the one way valve 144. The processis preferably repeated several times, slowly increasing the spinal arcin the cervical region and placing pressure on the thoracic region asthe level of tolerance increases. In addition, the first, second, andthird bladders 116, 118, and 119 can be held in an inflated state at orslightly below the level of tolerance for varying periods of time up toten to twenty minutes. Through such repetition, the cervical spine,thoracic spine and surrounding tissue receive a workout promotingcellular exchange in and around the intervertebral disc and a forwardcurve is reinstated into the cervical spine while achieving proper spineconfiguration in the thoracic region. FIGS. 23A and 23B illustrate theeffects of the traction and exercise devices 210 of some embodiments onthe cervical and thoracic spine.

With reference to FIGS. 24-27, an adjustable spacer component 150A and aspacer component 150B can be provided in some implementations of atraction system 110 to provide for lateral flexion traction. Forexample, FIG. 24 is a schematic top view of a patient positioned onanother embodiment of a decompression and traction system, showingpneumatic air chambers comprising first, second, and third inflatablebladders 116, 118, and 119, a first adjustable wedge-shaped spacercomponent 150A configured to be selectively coupled to the frame toadjust a position of the second inflatable bladder, and a secondadjustable wedge-shaped spacer component 150B configured to beselectively coupled to the frame to adjust a position of the thirdinflatable bladder. In the shown configuration, the first spacercomponent 150A is in a vertical orientation and adjusts the position ofthe second inflatable bladder to provide an even distribution of forcegenerally along a force vector in the −Y and +Z plane without providingany lateral flexion traction to the patient. In the shown configuration,the second spacer component 150B is in a vertical orientation andadjusts the position of the third inflatable bladder to provide an evendistribution of force generally along a force vector in the +Y and +Zplane without providing any lateral flexion traction to the patient.

FIG. 25 shows a configuration wherein the first spacer component 150A ismoved to adjust the position of the second inflatable bladder to providean uneven distribution of force on one side of the patient in that aforce vector is directed, for example, in a −Y, +Z, and −X direction.For example, the spacer component is turned or rotated to a horizontalposition, whereby the wedge shape of the spacer contacts the secondinflatable bladder and causes the bladder to deflect in one lateraldirection more than another lateral direction. As shown, the spacer isplaced in right horizontal position and causes more deflection on theright side of the patient. In other configurations, the spacer can bepositioned in a left horizontal position to cause more deflection on theleft side of the patient. Based on the positioning of the spacer, thesecond bladder can expand in an angular direction. Turning the spacercomponent sideways creates lateral flexion traction by forcing theshoulder/trapezius down while the head is held in traction.

In the configuration shown in FIG. 25, the second spacer component 150Bis moved to adjust the position of the third inflatable bladder toprovide an uneven distribution of force on one side of the patient inthat a force vector is directed, for example, in a +Y, +Z, and −Xdirection. For example, the spacer component is turned or rotated to ahorizontal position, whereby the wedge shape of the spacer contacts thethird inflatable bladder and causes the bladder to deflect in onelateral direction more than another lateral direction. As shown, thespacer is placed in right horizontal position and causes more deflectionon the right side of the patient. In other configurations, the spacercan be positioned in a left horizontal position to cause more deflectionon the left side of the patient. Based on the positioning of the spacer,the third bladder can expand in an angular direction. Turning the spacercomponent sideways creates lateral flexion traction by forcing the headup while the shoulder/trapezius is held in traction. In certainembodiments, the spacer component 150B can be moved to adjust theposition of the third inflatable bladder to provide an uneven forcedistribution of force on one side of the patient, as described herein,to treat a misalignment or deformity of the spine which causes thecervical spine to angle or curve in the +X or −X direction. For example,if the cervical spine of a patient is angled or curved in the +Xdirection, a −X force can be imparted to restore the cervical spine toits proper configuration. If the cervical spine of a patient is angledor curved in the −X direction, a +X force can be imparted to restore thecervical spine to its proper configuration.

FIG. 26 is a bottom view of the embodiment of FIG. 24 and shows thespacer component 150A in a vertical position that adjusts the positionof the second inflatable bladder to provide an even distribution offorce generally along a force vector in the −Y and +Z plane, but doesnot direct force laterally in a −X or +X direction. FIG. 26 shows thespacer component 150B in a vertical position that adjusts the positionof the third inflatable bladder to provide an even distribution of forcegenerally along a force vector in the +Y and +Z plane, but does notdirect force laterally in a −X or +X direction. FIG. 27 is a bottom viewof the embodiment of FIG. 24, showing a configuration wherein the firstspacer component 150A is moved to adjust the position of the secondinflatable bladder to provide an uneven distribution of force to apatient in that a force vector is directed, for example, in a −Y, +Z,and −X direction as described in connection with FIG. 25. The lowerlinear displacement pneumatic air chamber is adjusted with a rotatingwedge shaped spacer component, allowing clinicians to increase the angleand force of the mid (−Y)/(+Z) vector of this pneumatic air chamber.When adjusted to the right or left horizontal position, the rotatingwedge allows clinicians to unilaterally increase and rotate the (−Y)directional component on either the right or left side (+/−X) of theupper thoracic region, producing lateral flexion traction. The rotatingwedge shaped spacer component can be removed in some implementations toaccommodate extreme kyphotic thoracic spines. In the configuration ofFIG. 27, the second spacer component 150B is moved to adjust theposition of the third inflatable bladder to provide an unevendistribution of force to a patient in that a force vector is directed,for example, in a +Y, _Z, and −X direction as described in connectionwith FIG. 25. The upper linear displacement pneumatic air chamber isadjusted with a rotating wedge shaped spacer component allowingclinicians to increase the angle and force of the mid (+Y)/(+Z) vectorof this pneumatic air chamber. When adjusted to the right or lefthorizontal position, the rotating wedge allows clinicians tounilaterally increase and rotate the (+Y) directional component oneither the right or left side (+/−X) of the occiput, producing lateralflexion traction. The rotating wedge shaped spacer component can beremoved in some implementations.

While three expandable bladders 116, 118, and 119 are described withrespect to FIGS. 15-27, certain embodiments may employ only two of theinflatable bladders 116, 118, and 119, as shown in FIGS. 1-14, or onlyone of the inflatable bladders 116, 118, and 119. For example, in someembodiments, a decompression and traction system 310 may include onlythe first inflatable bladder 116 and the third inflatable bladder 119 asshown in FIG. 28. Such an embodiment may be less expensive tomanufacture than an embodiment having three inflatable bladders. Asdescribed herein, the first inflatable bladder 116 and third inflatablebladder 119 can be employed to apply −Y+Z+Y force vectors to thecervical spine while +Z/+Y force vectors are applied to the occiput. Thecervical spine's lordotic curve is powerfully decompressed and enhancedwhile the occipital-cervical junction is decompressed. Such anembodiment may be advantageous if treatment of the thoracic spine is notdesired. For example, in some embodiments, damage to the thoracic spineor an obstruction, such as a tumor or implant, may make the applicationof force to the thoracic spine undesirable. The system 310 may beutilized to treat symptoms associated with compression, damage,deformity, and/or misalignment of the cervical spine and theoccipital-cervical junction, including, for example, headaches, neckpain, and arm pain, which may be caused by pinched nerves. In certainembodiments, the decompression and traction system 310 can include aspacer component 150B as described with respect to the decompression andtraction system 210 as shown in FIGS. 15-27.

In some embodiments, a similar application of force can be imparted bythe system 210 through selective inflation of the bladders 119 and 116without inflation of the bladder 118 or with minimal inflation of thebladder 118. As described herein, in some embodiments, a two pump systemor a three pump system can be employed to alternate or unevenly inflatethe pneumatic air chambers. For example, in some embodiments, a firstpump can be employed to inflate the first and third inflatable bladders116 and 119 and a second pump can be employed to inflate the secondinflatable bladder 118.

In some embodiments, a decompression and traction system 410 may includeonly the second inflatable bladder 118 and the third inflatable bladder119 as shown in FIG. 29. Such an embodiment may be less expensive tomanufacture than an embodiment having three inflatable bladders. In someembodiments, the system 410 includes a pad or cushion 436 configured tobe positioned against the cervical spine when the system 410 is securedto a user. As described herein, the second bladder 118 and thirdinflatable bladder 119 can be employed to decompress a hyper kyphoticarea of the upper thoracic spine with a combination +Z/−Y forcemid-vector while +Z/+Y force vectors are simultaneously applied to theocciput to decompress the occipital-cervical junction. Thoracichyper-kyphosis is simultaneously reduced while the occipital-cervicaljunction is decompressed. In certain embodiments, the second inflatablebladder 118 can be employed to apply a −Y force vector to the upperthoracic spine, and the third inflatable bladder 119 can be employed toapply a +Y force vector to the occipital-cervical junction. In someembodiments, the system 310 can be used to impart linear traction to thespine. In certain embodiments, the decompression and traction system 410can include a spacer component 150A as described with respect to thedecompression and traction system 210 as shown in FIGS. 15-27. Incertain embodiments, the decompression and traction system 410 caninclude a spacer component 150B as described with respect to thedecompression and traction system 210 as shown in FIGS. 15-27.

In some embodiments, a similar application of force can be imparted bythe system 210 through selective inflation of the bladders 119 and 118without inflation of the bladder 116 or with minimal inflation of thebladder 116. As described herein, in some embodiments, a two pump systemor a three pump system can be employed to alternate or unevenly inflatethe pneumatic air chambers. For example, in some embodiments, a firstpump can be employed to inflate the second and third inflatable bladders118 and 119 and a second pump can be employed to inflate the firstinflatable bladder 116. By inflating the bladders 119 and 118 withoutinflating the bladder 116 or with minimal inflation of the bladder 116,linear traction can be imparted to the spine.

FIG. 30 shows a patient and an embodiment of a decompression andtraction system 510 having an elongated inflatable bladder 518. Theelongated inflatable bladder 518 can extend from the neck support to themid-thoracic spine when the decompression and traction system 510 issecured to the user. In some embodiments as described herein, themid-thoracic spine can include the T4-T9 vertebrae, the T5-T8 vertebrae,or the T6-T7 vertebrae. In addition to the application of forces to theupper thoracic spine, as described herein, the inflatable bladder 518can be configured for inflation and simultaneous application of force tothe mid-thoracic spine, when the patient is in a treatment position, todecompress the spine into its proper curved configuration with a +Zforce vector, and in some embodiments, −Y and/or +Y for force vectors,being applied to the mid-thoracic spine. The elongated inflatablebladder 518 can apply pressure to the apex of the kyphosis of thethoracic spine. In some embodiments, the thoracic hyper-kyphosis can befurther reduced by the application of force to the mid-thoracic spine.The elongated bladder 518 can directly contact the upper 25%-75% of thethoracic spine. In certain embodiments, the elongated bladder 518 candirectly contact the upper 25% to 45%, upper 25% to 50%, upper 25% to55%, upper 25% to 60%, upper 25% to 65%, or upper 25% to 70% of thethoracic spine. In certain embodiments, the elongated bladder 518 candirectly contact the upper 50% of the thoracic spine.

As described herein, the inflatable bladder 518 can be inflated using apump assembly. A pump for inflation of the inflatable bladder 518 can bethe same as or a separate pump from one or more pumps used for inflationof the inflatable bladders 116 and 119. In some embodiments, two or morepumps can be employed to alternate or unevenly inflate portions of theelongated inflatable bladder 518. For example, in some embodiments, afirst pump can be employed to inflate a first portion of the elongatedinflatable bladder 518 positioned to apply a force to the upper thoracicspine and a second pump can be employed to inflate a second portion ofthe elongated inflatable bladder 518 positioned to apply a force to themid-thoracic spine. Although a single elongated inflatable bladder 518is shown in FIG. 30, in some embodiments, a separate inflatable bladdermay be employed to apply a force to the mid-thoracic spine. In suchembodiments, the separate inflatable bladder configured to apply a forceto the mid-thoracic spine can be inflated using a pump that can beseparate from or shared with the inflatable bladder positioned to applya force to the upper thoracic spine.

In certain embodiments, the decompression and traction system 510 caninclude one or more spacer components having the same or similarfeatures to spacer components 150, 150A, and 150B. For example, in someembodiments, the decompression and traction system 510 can include aspacer between a portion of the frame 112 and the elongated inflatablebladder 518. The spacer can be employed to adjust the angulation of theinflatable bladder 518 during inflation. In certain embodiments, thedecompression and traction system 510 can include a spacer between aportion of the frame 112 and the inflatable bladder 119. The spacer canbe employed to adjust the angulation of the inflatable bladder 119during inflation. Spacers used in the decompression and traction system510 can include a wedge-shaped spacer, a rotatable spacer, and/or aspacer in a horizontal position that is configured to adjust theangulation of the inflatable bladder portion 119 or the inflatablebladder portion 518 during inflation to provide lateral flexiontraction. Other spacer systems are contemplated and can also be used.For example, any component or device that can be selectively adjustedand can contact at least a portion of the inflatable bladder portion 119and/or the inflatable bladder portion 518 can be used to impart lateralflexion traction. Additionally, in some cases a component or device neednot be adjustable, for example, a spacer or other component could beprovided on a traction device to cause the inflatable bladder portion119 and/or the inflatable bladder portion 518 to consistently providefor lateral flexion traction on one side, while other systems canprovide for lateral flexion traction on the other side. Additionally,while adjustments made with the spacer may be rotational, othermovements or adjustments can be made with other mechanisms andarrangements, such as by sliding, for example.

While three expandable bladders 116, 518, and 119 are described withrespect to FIG. 30, certain embodiments may employ only the elongatedinflatable bladder portion 518 or only the elongated inflatable bladderportion 518 and one of the inflatable bladder portion 116 and theinflatable bladder portion 119.

The various devices, systems and methods described above provide anumber of ways to carry out some preferred embodiments of the invention.Of course, it is to be understood that not necessarily all objectives oradvantages described may be achieved in accordance with any particularembodiment described herein. Thus, for example, those skilled in the artwill recognize that the devices and systems may be made and the methodsmay be performed in a manner that achieves or optimizes one advantage orgroup of advantages as taught herein without necessarily achieving otherobjectives or advantages as may be taught or suggested herein.

Furthermore, the skilled artisan will recognize the interchangeabilityof various features from different embodiments. Similarly, the variouscomponents, features and steps discussed above, as well as other knownequivalents for each such component, feature or step, can be mixed andmatched by one of ordinary skill in this art to make devices and systemsand perform methods in accordance with principles described herein.

Although the invention has been disclosed in the context of someembodiments and examples, it will be understood by those skilled in theart that the invention extends beyond these specifically disclosedembodiments to other alternative embodiments and/or uses and obviousmodifications and equivalents thereof. Accordingly, the invention is notintended to be limited by the specific disclosures of preferredembodiments herein.

1-13. (canceled)
 14. A method of treating a spine, the method comprisingsteps of: securing a traction device to a head of a user, the tractiondevice comprising a support frame having a transverse neck supportprojecting upwardly from a base of the support frame and first andsecond inflatable bladder portions coupled to the neck support, whereinsecuring the traction device to the head comprises positioning thetraction device such that the first inflatable bladder portiontransverses a cervical spine of the user, and such that the secondinflatable bladder portion transverses an occiput of the user; expandingthe first inflatable bladder portion in a direction outward from theneck support and toward and substantially normal to the cervical spineto force the cervical spine to curve forwardly; expanding the firstinflatable bladder portion in a transverse direction to apply an angulartraction to the cervical spine; and expanding the second inflatablebladder portion in a direction toward the occiput to apply an angulartraction to the cervical spine.
 15. The method of claim 14, comprisingthe step of alternately inflating and deflating the first and secondbladder portions.
 16. The method of claim 15, comprising the step ofrepeating inflation and deflation of the first and second bladderportions.
 17. The method of claim 14, wherein the second inflatablebladder portion has a semi-ellipsoidal configuration upon inflation. 18.The method of claim 14, wherein the traction device comprises a thirdinflatable bladder portion coupled to the neck support, wherein securingthe traction device to the head comprises positioning the tractiondevice such that the third inflatable bladder portion transverses anupper thoracic spine of the user.
 19. (canceled)
 20. The method of claim14, wherein the traction device comprises a valve positioned incommunication with a pump system, the first inflatable bladder portion,and the second inflatable bladder portion, wherein the method furthercomprises directing flow from the pump system through the valve to thefirst inflatable bladder portion and the second inflatable bladderportion. 21-27. (canceled)
 28. A traction device comprising: a framehaving a base and a neck support coupled to the base to support the neckof a user during use; an inflatable bladder portion coupled to the necksupport, the inflatable bladder portion configured to expand in anangular direction from the neck support; and wherein upon the inflatablebladder portion expanding in the angular direction, the inflatablebladder portion bears angularly against the back of the upper thoracicregion and the mid thoracic region of the user as the inflatable bladderis inflated and forces the thoracic spine to decompress and reduceshyper-kyphosis of the upper thoracic spine and the mid thoracic spine.29. The traction device of claim 28, wherein the inflatable bladderportion is a first inflatable bladder portion, wherein the angulardirection is a first angular direction, the traction device furthercomprising a second inflatable bladder portion coupled to the necksupport, the second inflatable bladder portion bladder portion beingexpandable in a second angular direction from the neck support toward aocciput of the user upon inflation, wherein upon the second inflatablebladder portion expanding in the second angular direction, the secondinflatable bladder portion bears angularly against the occiput of theuser as the second inflatable bladder is inflated and forces theoccipital-cervical junction to decompress.
 30. The traction device ofclaim 29, further comprising a third inflatable bladder portion coupledto the neck support, the third inflatable bladder portion configured toexpand in an outward direction from the neck support toward the neck ofthe user and expandable in a transverse direction substantially normalto the outward direction upon inflation, wherein upon the thirdinflatable bladder portion expanding in the outward direction, the thirdinflatable bladder portion bears outwardly against the back of the neckof the user as the third inflatable bladder is inflated and forces thecervical spine to curve forwardly, and upon expanding in the transversedirection, the third inflatable bladder portion applies an angulartraction to the cervical spine as the third inflatable bladder isinflated.
 31. The traction device of claim 28, wherein the inflatablebladder portion is a first inflatable bladder portion, the tractiondevice further comprising a second inflatable bladder portion coupled tothe neck support, the second inflatable bladder portion configured toexpand in an outward direction from the neck support toward the neck ofthe user and expandable in a transverse direction substantially normalto the outward direction upon inflation, wherein upon the secondinflatable bladder portion expanding in the outward direction, thesecond inflatable bladder portion bears outwardly against the back ofthe neck of the user as the second inflatable bladder is inflated andforces the cervical spine to curve forwardly, and upon expanding in thetransverse direction, the second inflatable bladder portion applies anangular traction to the cervical spine as the second inflatable bladderis inflated.
 32. The traction device of claim 28, further comprising aspacer configured to be coupled between a portion of the frame and theinflatable bladder portion to adjust the angulation of the inflatablebladder portion during inflation.
 33. The traction device of claim 32,wherein the spacer is a wedge-shaped spacer.
 34. The traction device ofclaim 32, wherein the spacer is rotatable.
 35. A method of treating aspine, the method comprising steps of: securing a traction device to ahead of a user, the traction device comprising a support frame having atransverse neck support projecting upwardly from a base of the supportframe and first and second inflatable bladder portions coupled to theneck support, wherein securing the traction device to the head comprisespositioning the traction device such that the first inflatable bladderportion transverses an upper thoracic spine of the user, and such thatthe second inflatable bladder portion transverses an occiput of theuser; expanding the first inflatable bladder portion in a directiontoward the upper thoracic spine to force the thoracic spine todecompress and reduce hyper-kyphosis of the upper thoracic spine; andexpanding the second inflatable bladder portion in a direction towardthe occiput to apply an angular traction to a cervical spine of theuser.
 36. The method of claim 35, comprising the step of alternatelyinflating and deflating the first and second bladder portions.
 37. Themethod of claim 36, comprising the step of repeating inflation anddeflation of the first and second bladder portions.
 38. The method ofclaim 35, wherein the second inflatable bladder portion has asemi-ellipsoidal configuration upon inflation.
 39. The method of claim35, wherein the traction device comprises a third inflatable bladderportion coupled to the neck support, wherein securing the tractiondevice to the head comprises positioning the traction device such thatthe third inflatable bladder portion transverses a cervical spine of theuser.
 40. The method of claim 39, wherein the third inflatable bladderportion is positioned between the first inflatable bladder portion andthe second inflatable bladder portion.
 41. The method of claim 35,wherein the traction device comprises a valve positioned incommunication with a pump system, the first inflatable bladder portion,and the second inflatable bladder portion, wherein the method furthercomprises directing flow from the pump system through the valve to thefirst inflatable bladder portion and the second inflatable bladderportion.